diff --git "a/sample.json" "b/sample.json" new file mode 100644--- /dev/null +++ "b/sample.json" @@ -0,0 +1,4173 @@ +[ + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Peoria", + "state": "IL", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "72241", + "recalling_firm": "Kalman Health & Wellness, Inc. dba Essential Wellness Pharma", + "address_1": "4625 N University St", + "address_2": "N/A", + "postal_code": "61614-5828", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "Nationwide", + "recall_number": "D-321-2016", + "product_description": "Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.", + "product_quantity": "1 vial", + "reason_for_recall": "Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.", + "recall_initiation_date": "20150903", + "center_classification_date": "20151117", + "termination_date": "20171229", + "report_date": "20151125", + "code_info": "Lot #: 072915, Exp 10/29/2015", + "scrapedAt": "2026-05-14T17:41:49.939Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Ongoing", + "city": "San Juan Del Rio", + "state": "N/A", + "country": "Mexico", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "86162", + "recalling_firm": "Albek De Mexico S.A. 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Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.", + "recall_initiation_date": "20200730", + "center_classification_date": "20201117", + "report_date": "20201125", + "code_info": "1931102AL", + "scrapedAt": "2026-05-14T17:41:50.012Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Ongoing", + "city": "Exton", + "state": "PA", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "97808", + "recalling_firm": "ProRx LLC", + "address_1": "619 Jeffers Cir", + "address_2": "N/A", + "postal_code": "19341-2540", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "TX and UT", + "recall_number": "D-0115-2026", + "product_description": "Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04", + "product_quantity": "8,400 vials", + "reason_for_recall": "Lack of Assurance of Sterility", + "recall_initiation_date": "20251015", + "center_classification_date": "20251027", + "report_date": "20251105", + "code_info": "Lot, Best Use Date (BUD): Lot PRORX050925-1, BUD November 4, 2025; Lot ProRx051425-5, BUD November 10, 2025; Lot ProRx051425-6, BUD November 10, 2025", + "scrapedAt": "2026-05-14T17:41:50.051Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Parsippany", + "state": "NJ", + "country": "United States", + "classification": "Class II", + "openfda": { + "application_number": [ + "ANDA040422" + ], + "brand_name": [ + "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE" + ], + "generic_name": [ + "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE" + ], + "manufacturer_name": [ + "Teva Pharmaceuticals USA, Inc." + ], + "product_ndc": [ + "0555-0775", + "0555-0971", + "0555-0972", + "0555-0776", + "0555-0777", + "0555-0973", + "0555-0974" + ], + "product_type": [ + "HUMAN PRESCRIPTION DRUG" + ], + "route": [ + "ORAL" + ], + "substance_name": [ + "AMPHETAMINE ASPARTATE MONOHYDRATE", + "AMPHETAMINE SULFATE", + "DEXTROAMPHETAMINE SACCHARATE", + "DEXTROAMPHETAMINE SULFATE" + ], + "rxcui": [ + "541363", + "541878", + "541892", + "577957", + "577961", + "687043", + "1009145" + ], + "spl_id": [ + "88468f3d-7d03-4cee-aabf-3abc8c9b5e38" + ], + "spl_set_id": [ + "cffbbb15-d776-41ae-a8a6-687f2c07bfa4" + ], + "package_ndc": [ + "0555-0971-02", + "0555-0775-02", + "0555-0972-02", + "0555-0776-02", + "0555-0777-02", + "0555-0973-02", + "0555-0974-02" + ], + "is_original_packager": [ + true + ], + "unii": [ + "6DPV8NK46S", + "G83415V073", + "O1ZPV620O4", + "JJ768O327N" + ] + }, + "product_type": "Drugs", + "event_id": "85712", + "recalling_firm": "Teva Pharmaceuticals USA", + "address_1": "400 Interpace Pkwy", + "address_2": "N/A", + "postal_code": "07054-1120", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "Nationwide within the United State and Puerto Rico.", + "recall_number": "D-1285-2020", + "product_description": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 5 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0971-02", + "product_quantity": "33,280 bottles", + "reason_for_recall": "Some bottles may contain mixed strengths of the product.", + "recall_initiation_date": "20200522", + "center_classification_date": "20200604", + "termination_date": "20210525", + "report_date": "20200610", + "code_info": "Lot #: 42614718, Exp. date 02/2021", + "scrapedAt": "2026-05-14T17:41:50.097Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Allegan", + "state": "MI", + "country": "United States", + "classification": "Class II", + "openfda": { + "application_number": [ + "M012" + ], + "brand_name": [ + "EQUALINE NASAL" + ], + "generic_name": [ + "OXYMETAZOLINE HCL" + ], + "manufacturer_name": [ + "United Natural Foods, Inc. dba UNFI" + ], + "product_ndc": [ + "41163-703" + ], + "product_type": [ + "HUMAN OTC DRUG" + ], + "route": [ + "NASAL" + ], + "substance_name": [ + "OXYMETAZOLINE HYDROCHLORIDE" + ], + "rxcui": [ + "1000990" + ], + "spl_id": [ + "00703ca9-7bc4-48a8-9e49-3688fffce57f" + ], + "spl_set_id": [ + "69308693-a094-42a9-a041-e73647a25cc1" + ], + "package_ndc": [ + "41163-703-10" + ], + "is_original_packager": [ + true + ], + "unii": [ + "K89MJ0S5VY" + ] + }, + "product_type": "Drugs", + "event_id": "88905", + "recalling_firm": "Perrigo Company PLC", + "address_1": "515 Eastern Ave", + "address_2": "", + "postal_code": "49010-9070", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "Nationwide in the USA", + "recall_number": "D-0623-2022", + "product_description": "No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-703-10", + "product_quantity": "1,560 bottles", + "reason_for_recall": "CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.", + "recall_initiation_date": "20211026", + "center_classification_date": "20220223", + "termination_date": "20230929", + "report_date": "20220302", + "code_info": "Batch: 1BK0964, Exp 01/31/2023", + "more_code_info": "", + "scrapedAt": "2026-05-14T17:41:50.135Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Lake Forest", + "state": "IL", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "74057", + "recalling_firm": "Pharmedium Services, LLC", + "address_1": "150 N Field Dr Ste 350", + "address_2": "N/A", + "postal_code": "60045-2506", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "E-Mail", + "distribution_pattern": "Nationwide", + "recall_number": "D-1398-2016", + "product_description": "2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride,\t 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8102, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-102-48", + "product_quantity": "940 bags", + "reason_for_recall": "Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.", + "recall_initiation_date": "20160505", + "center_classification_date": "20160716", + "termination_date": "20180306", + "report_date": "20160727", + "code_info": "Lot Number 160380168M , Exp. Date 5/8/2016 ; Lot Number 160410137M , Exp. Date 5/11/2016 ; Lot Number 160460150M , Exp. Date 5/16/2016 ; Lot Number 160530279M , Exp. Date 5/23/2016 ; Lot Number 160590185M , Exp. Date 5/29/2016 ; Lot Number 160630160M , Exp. Date 6/2/2016 ; Lot Number 160680179M , Exp. Date 6/7/2016 ; Lot Number 160730238M , Exp. Date 6/12/2016 ; Lot Number 160840215M , Exp. Date 6/23/2016 ; Lot Number 160880193M , Exp. Date 6/27/2016 ; Lot Number 160890187M , Exp. Date 6/28/2016 ;", + "more_code_info": "", + "scrapedAt": "2026-05-14T17:41:50.169Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "New York", + "state": "NY", + "country": "United States", + "classification": "Class III", + "openfda": { + "application_number": [ + "NDA020779" + ], + "brand_name": [ + "VIRACEPT" + ], + "generic_name": [ + "NELFINAVIR MESYLATE" + ], + "manufacturer_name": [ + "AGOURON" + ], + "product_ndc": [ + "63010-010", + "63010-027" + ], + "product_type": [ + "HUMAN PRESCRIPTION DRUG" + ], + "route": [ + "ORAL" + ], + "substance_name": [ + "NELFINAVIR MESYLATE" + ], + "rxcui": [ + "212118", + "311924", + "403978", + "542370" + ], + "spl_id": [ + "4af6d4ca-b410-48e3-925e-ce23a14db18a" + ], + "spl_set_id": [ + "e72c2bc6-9462-4a2e-8e1d-b97592376cbd" + ], + "package_ndc": [ + "63010-010-30", + "63010-027-70" + ], + "is_original_packager": [ + true + ], + "upc": [ + "0363010010309" + ], + "unii": [ + "98D603VP8V" + ] + }, + "product_type": "Drugs", + "event_id": "68660", + "recalling_firm": "Pfizer Inc.", + "address_1": "235 East 42nd Street", + "address_2": "N/A", + "postal_code": "10017-5703", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "Nationwide and Puerto Rico", + "recall_number": "D-1443-2014", + "product_description": "VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company, Distributed by: ViV Healthcare Company, Research Triangle Park, NC 27709 NDC 63010-027-70", + "product_quantity": "1200 tablets", + "reason_for_recall": "Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016.", + "recall_initiation_date": "20140708", + "center_classification_date": "20140717", + "termination_date": "20150706", + "report_date": "20140723", + "code_info": "Lot H45241, exp. 11/16", + "scrapedAt": "2026-05-14T17:41:50.215Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Ongoing", + "city": "Dania Beach", + "state": "FL", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "94788", + "recalling_firm": "Little Moon Essentials LLC", + "address_1": "501 Old Griffin Rd", + "address_2": "N/A", + "postal_code": "33004-2774", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "Nationwide USA and Ontario, Canada (2 retailers)", + "recall_number": "D-0572-2024", + "product_description": "Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 88260 2, NDC 70722-260-04; b) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88204 6, NDC 70722-260-02, Little Moon Essentials LLC Dania Beach, Fl 33004", + "product_quantity": "788 glass jars", + "reason_for_recall": "CGMP deviations", + "recall_initiation_date": "20240620", + "center_classification_date": "20240702", + "report_date": "20240710", + "code_info": "lot code No Expiration Date on product: a) 224010, b) 321260, 322260, 320280, 328080, 325021, 321121, 423010, 427110, 429120, 420220, 422140", + "scrapedAt": "2026-05-14T17:41:50.249Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Houston", + "state": "TX", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "81002", + "recalling_firm": "Pharm D Solutions, LLC", + "address_1": "1304 S Loop W", + "address_2": "N/A", + "postal_code": "77054-4010", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Press Release", + "distribution_pattern": "Nationwide", + "recall_number": "D-0194-2019", + "product_description": "Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1352-05", + "product_quantity": "9 vials", + "reason_for_recall": "Lack of Assurance of Sterility", + "recall_initiation_date": "20180910", + "center_classification_date": "20181101", + "termination_date": "20210205", + "report_date": "20181107", + "code_info": "Lot: 04262018:09 Discard by: 10/22/2018; 07022018:48 Discard by: 12/29/2018", + "scrapedAt": "2026-05-14T17:41:50.286Z" + }, + { + "_dataset": "drug/enforcement", + "country": "United States", + "city": "Chesterbrook", + "address_1": "1300 Morris Dr", + "reason_for_recall": "Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.", + "address_2": "", + "product_quantity": "60 vials", + "code_info": "Lot #s: 7800929, 7800931, Exp 02/15; 7800962, Exp 03/15", + "center_classification_date": "20130927", + "distribution_pattern": "Nationwide", + "state": "PA", + "product_description": "Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4496-22", + "report_date": "20131009", + "classification": "Class II", + "openfda": {}, + "recalling_firm": "AmeriSource Bergen", + "recall_number": "D-1066-2013", + "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", + "product_type": "Drugs", + "event_id": "66316", + "termination_date": "20141001", + "more_code_info": "", + "recall_initiation_date": "20130913", + "postal_code": "19087-5559", + "voluntary_mandated": "Voluntary: Firm initiated", + "status": "Terminated", + "scrapedAt": "2026-05-14T17:41:50.326Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Fountain Run", + "state": "KY", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "77601", + "recalling_firm": "Apace KY LLC", + "address_1": "12954 Fountain Run Rd", + "address_2": "N/A", + "postal_code": "42133-7914", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "E-Mail", + "distribution_pattern": "KY", + "recall_number": "D-1035-2017", + "product_description": "Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15", + "product_quantity": "1,483 cartons", + "reason_for_recall": "Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg", + "recall_initiation_date": "20170619", + "center_classification_date": "20170731", + "termination_date": "20180504", + "report_date": "20170809", + "code_info": "Lot: 16710, exp 07/2018", + "scrapedAt": "2026-05-14T17:41:50.364Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Dublin", + "state": "OH", + "country": "United States", + "classification": "Class II", + "openfda": { + "application_number": [ + "NDA200796" + ], + "brand_name": [ + "EDARBI" + ], + "generic_name": [ + "AZILSARTAN KAMEDOXOMIL" + ], + "manufacturer_name": [ + "Azurity Pharmaceuticals, Inc." + ], + "product_ndc": [ + "60631-040", + "60631-080" + ], + "product_type": [ + "HUMAN PRESCRIPTION DRUG" + ], + "route": [ + "ORAL" + ], + "substance_name": [ + "AZILSARTAN KAMEDOXOMIL" + ], + "rxcui": [ + "1091646", + "1091650", + "1091652", + "1091654" + ], + "spl_id": [ + "2f63b0e8-977a-4d22-9550-29ad1926a9de" + ], + "spl_set_id": [ + "52b27c75-9f5a-4816-bafd-dace9d7d2063" + ], + "package_ndc": [ + "60631-040-07", + "60631-040-30", + "60631-040-77", + "60631-080-07", + "60631-080-30", + "60631-080-77" + ], + "is_original_packager": [ + true + ], + "upc": [ + "0360631080308", + "0360631040302" + ] + }, + "product_type": "Drugs", + "event_id": "87512", + "recalling_firm": "Cardinal Health Inc.", + "address_1": "7000 Cardinal Pl", + "address_2": "N/A", + "postal_code": "43017-1091", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "FL, GA, SC", + "recall_number": "D-0429-2021", + "product_description": "Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328", + "product_quantity": "328 bottles", + "reason_for_recall": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.", + "recall_initiation_date": "20210315", + "center_classification_date": "20210524", + "termination_date": "20240617", + "report_date": "20210602", + "code_info": "78902-1", + "scrapedAt": "2026-05-14T17:41:50.410Z" + }, + { + "_dataset": "drug/enforcement", + "country": "United States", + "city": "Knoxville", + "address_1": "6216 Highland Place Way Ste 101-A", + "reason_for_recall": "Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility", + "address_2": "", + "product_quantity": "1558 ml total", + "code_info": "All lots distributed between November 2014 and May 2015; 05062015@32, 8/4/2015; 02272015@16, 5/28/2015; 03032015@33, 6/1/2015; 03042015@36, 6/2/2015; 03062015@43, 6/4/2015; 03092015@77, 6/7/2015; 03092015@92, 6/7/2015; 03132015@17, 11/2015; 03162015@23, 14/2015; 03172015@40, 5/2015; 03232015@39, 6/21/2015; 03242015@23, 6/22/2015; 03242015@29, 6/22/2015; 04162015@46, 7/15/2015; 04012015@8, 6/30/2015; 04062015@10, 7/5/2015; 04072015@17, 7/6/2015; 04142015@2, 7/13/2015; 04132015@34, 7/12/2015; 04202015@45, 7/19/2015; 04172015@63, 7/16/2015; 04272015@5, 7/26/2015; 05082015@44, 8/6/2015", + "center_classification_date": "20150915", + "distribution_pattern": "Nationwide", + "state": "TN", + "product_description": "HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN", + "report_date": "20150923", + "classification": "Class II", + "openfda": {}, + "recalling_firm": "The Compounding Pharmacy of America", + "recall_number": "D-1519-2015", + "initial_firm_notification": "Telephone", + "product_type": "Drugs", + "event_id": "71371", + "termination_date": "20160210", + "more_code_info": "", + "recall_initiation_date": "20150602", + "postal_code": "37919-4068", + "voluntary_mandated": "Voluntary: Firm initiated", + "status": "Terminated", + "scrapedAt": "2026-05-14T17:41:50.722Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Eatontown", + "state": "NJ", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "67022", + "recalling_firm": "West-Ward Pharmaceutical Corp.", + "address_1": "465 Industrial Way W", + "address_2": "N/A", + "postal_code": "07724-2209", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "Nationwide", + "recall_number": "D-367-2014", + "product_description": "Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd, Periyakalepet, Pondicherry. 605014 INDIA. NDC 0143-9749-10.", + "product_quantity": "20,534 bottles", + "reason_for_recall": "Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing", + "recall_initiation_date": "20131107", + "center_classification_date": "20131216", + "termination_date": "20140814", + "report_date": "20131225", + "code_info": "NDC 0143-9749-10 Lot: 1) 10BR001B, Exp Aug-2014 2) 10BR002B, Exp Aug-2014 3) 10BR003B Exp, Aug-2014 4) 10BR004B Exp, Aug-2014 5) 10BR005B Exp, Aug-2014 6) 10BR006B Exp, Aug-2014 7) 11BR001B Exp, Aug-2014 8) 11BR002B Exp, Jul-2015 9) 11BR003B Exp, Jul-2015 10) 11BR004B Exp, Jul-2015 11) 11BR005B Exp, Jul-2015 12) 11BR006B Exp, Jul-2015", + "scrapedAt": "2026-05-14T17:41:50.764Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Dublin", + "state": "OH", + "country": "United States", + "classification": "Class II", + "openfda": { + "application_number": [ + "ANDA077857" + ], + "brand_name": [ + "ENOXAPARIN SODIUM" + ], + "generic_name": [ + "ENOXAPARIN SODIUM" + ], + "manufacturer_name": [ + "Sandoz Inc" + ], + "product_ndc": [ + "0781-3238", + "0781-3246", + "0781-3256", + "0781-3262", + "0781-3268", + "0781-3298", + "0781-3299" + ], + "product_type": [ + "HUMAN PRESCRIPTION DRUG" + ], + "route": [ + "SUBCUTANEOUS" + ], + "substance_name": [ + "ENOXAPARIN SODIUM" + ], + "rxcui": [ + "854228", + "854235", + "854238", + "854241", + "854245", + "854248", + "854252" + ], + "spl_id": [ + "82c50153-58b8-4c35-8fc2-1d9b3d3ac7de" + ], + "spl_set_id": [ + "38f60bd8-b518-4098-a808-b8f5a3ae6a3a" + ], + "package_ndc": [ + "0781-3238-01", + "0781-3238-63", + "0781-3246-02", + "0781-3246-64", + "0781-3256-03", + "0781-3256-66", + "0781-3262-04", + "0781-3262-68", + "0781-3268-05", + "0781-3268-69", + "0781-3298-04", + "0781-3298-68", + "0781-3299-05", + "0781-3299-69" + ], + "is_original_packager": [ + true + ], + "unii": [ + "8NZ41MIK1O" + ] + }, + "product_type": "Drugs", + "event_id": "89450", + "recalling_firm": "CARDINAL HEALTHCARE", + "address_1": "7200 Cardinal Pl W", + "address_2": "", + "postal_code": "43017-1094", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "Nationwide USA", + "recall_number": "D-0179-2024", + "product_description": "Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540. NDC: 0781-3299-69", + "product_quantity": "2 units", + "reason_for_recall": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.", + "recall_initiation_date": "20220126", + "center_classification_date": "20231226", + "termination_date": "20240929", + "report_date": "20240103", + "code_info": "Batch SAH06821A", + "more_code_info": "", + "scrapedAt": "2026-05-14T17:41:50.798Z" + }, + { + "_dataset": "drug/enforcement", + "country": "United States", + "city": "Olive Branch", + "address_1": "1 & 2", + "reason_for_recall": "Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.", + "address_2": "154 Downing Street", + "product_quantity": "Unknown", + "code_info": "Lot #: 15617VP03, 15617VP01, 15617VP-02, Exp 7/31/2019; 15617VP06, 15617VP05, Exp 11/30/2019; 15617VP04, 15618004, 15618002, Exp 12/31/2019; 15618009, 15618008, Exp 2/29/2020; 15618011, Exp 3/31/2020.", + "center_classification_date": "20180907", + "distribution_pattern": "Nationwide in the USA and Puerto Rico", + "state": "MS", + "product_description": "Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-156-04.", + "report_date": "20180829", + "classification": "Class I", + "openfda": {}, + "recalling_firm": "Westminster Pharmaceuticals LLC", + "recall_number": "D-1178-2018", + "initial_firm_notification": "Letter", + "product_type": "Drugs", + "event_id": "80719", + "termination_date": "20200603", + "more_code_info": "", + "recall_initiation_date": "20180803", + "postal_code": "38654", + "voluntary_mandated": "Voluntary: Firm initiated", + "status": "Terminated", + "scrapedAt": "2026-05-14T17:41:50.874Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Boca Raton", + "state": "FL", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "78553", + "recalling_firm": "KRS Global Biotechnology, Inc", + "address_1": "791 Park of Commerce Blvd Ste 600", + "address_2": "N/A", + "postal_code": "33487-3633", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "Nationwide in the USA, Bermuda, and New Zealand", + "recall_number": "D-0176-2018", + "product_description": "Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.", + "product_quantity": "2,239 vials", + "reason_for_recall": "Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.", + "recall_initiation_date": "20171116", + "center_classification_date": "20180108", + "termination_date": "20200511", + "report_date": "20180117", + "code_info": "Lot: 08302017@11 BUD: 2/26/2018", + "more_code_info": "", + "scrapedAt": "2026-05-14T17:41:50.908Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Chesapeake", + "state": "VA", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "91466", + "recalling_firm": "Sentara Infusion Services", + "address_1": "535 Independence Pkwy Ste 300", + "address_2": "N/A", + "postal_code": "23320-5176", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Telephone", + "distribution_pattern": "Dispensed to Patients Nationwide.", + "recall_number": "D-0296-2023", + "product_description": "HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 60ML, 100ML, 250ML; pain, Rx only, used with a Curlin pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 00409-2634-50", + "product_quantity": "37 bags", + "reason_for_recall": "Lack of sterility assurance", + "recall_initiation_date": "20221227", + "center_classification_date": "20230215", + "termination_date": "20260220", + "report_date": "20230222", + "code_info": "Beyond Use Date: December 24-31, 2022", + "scrapedAt": "2026-05-14T17:41:50.942Z" + }, + { + "_dataset": "drug/enforcement", + "country": "United States", + "city": "Knoxville", + "address_1": "6216 Highland Place Way Ste 101-A", + "reason_for_recall": "Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility", + "address_2": "", + "product_quantity": "24 pellets", + "code_info": "All lots distributed between November 2014 and May 2015; 03032015@43, 8/30/2015", + "center_classification_date": "20150915", + "distribution_pattern": "Nationwide", + "state": "TN", + "product_description": "Testosterone 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN", + "report_date": "20150923", + "classification": "Class II", + "openfda": {}, + "recalling_firm": "The Compounding Pharmacy of America", + "recall_number": "D-1744-2015", + "initial_firm_notification": "Telephone", + "product_type": "Drugs", + "event_id": "71371", + "termination_date": "20160210", + "more_code_info": "", + "recall_initiation_date": "20150602", + "postal_code": "37919-4068", + "voluntary_mandated": "Voluntary: Firm initiated", + "status": "Terminated", + "scrapedAt": "2026-05-14T17:41:50.983Z" + }, + { + "_dataset": "drug/enforcement", + "country": "United States", + "city": "Vancouver", + "address_1": "14301 Se 1st St", + "reason_for_recall": "Labeling: Label Mixup; FAMOTIDINE Tablet, 20 mg may be potentially mislabeled as CARVEDILOL PHOSPHATE ER, Capsule, 20 mg, NDC 00007337113, Pedigree: W003225, EXP: 6/17/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003506, EXP: 6/21/2014; FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003507, EXP: 6/21/2014; MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 0037822500", + "address_2": "", + "product_quantity": "700 Tablets", + "code_info": "FAMOTIDINE Tablet, 20 mg has the following codes Pedigree: W003226, EXP: 6/17/2014; Pedigree: W003507, EXP: 6/21/2014; Pedigree: W003508, EXP: 6/21/2014; Pedigree: W003764, EXP: 6/26/2014; Pedigree: W003406, EXP: 6/19/2014.", + "center_classification_date": "20140116", + "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", + "state": "WA", + "product_description": "FAMOTIDINE Tablet, 20 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 16714036104", + "report_date": "20140122", + "classification": "Class II", + "openfda": {}, + "recalling_firm": "Aidapak Services, LLC", + "recall_number": "D-518-2014", + "initial_firm_notification": "Telephone", + "product_type": "Drugs", + "event_id": "65707", + "termination_date": "20140207", + "more_code_info": "", + "recall_initiation_date": "20130702", + "postal_code": "98684-3501", + "voluntary_mandated": "Voluntary: Firm initiated", + "status": "Terminated", + "scrapedAt": "2026-05-14T17:41:51.016Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Asbury Park", + "state": "NJ", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "78991", + "recalling_firm": "Flawless Beauty LLC", + "address_1": "1215 Main St", + "address_2": "N/A", + "postal_code": "07712-5940", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Press Release", + "distribution_pattern": "Product was distributed U.S.A. nationwide.", + "recall_number": "D-0333-2018", + "product_description": "Ling Zhi capsules", + "product_quantity": "N/A", + "reason_for_recall": "Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.", + "recall_initiation_date": "20180119", + "center_classification_date": "20180205", + "termination_date": "20180913", + "report_date": "20180214", + "code_info": "all lots", + "scrapedAt": "2026-05-14T17:41:51.048Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Ongoing", + "city": "Dawsonville", + "state": "GA", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "92054", + "recalling_firm": "Direct Rx", + "address_1": "94 Worldwide Dr", + "address_2": "", + "postal_code": "30534-6828", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "Nationwide in the USA", + "recall_number": "D-0508-2023", + "product_description": "Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.", + "product_quantity": "349 bottles", + "reason_for_recall": "CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.", + "recall_initiation_date": "20230322", + "center_classification_date": "20230406", + "report_date": "20230412", + "code_info": "Lots: a) 03FE2318, Exp. 8/31/24; b) 27FE2315, 28FE2313, 02MA2306, 21SE2201, 16NO2216, 17NO2216, 24FA2314, Exp. 8/31/24; 17FE2203, 12AP2204, 17MA2205, Exp. 3/31/23; 21JU2206, 22JU2220, 12JY2206, Exp. 5/31/23; 10AU2209, Exp. 6/30/23; 14DE2215, Exp. 9/30/24; 05JA2304, 27JA2301, Exp. 11/30/24.", + "more_code_info": "", + "scrapedAt": "2026-05-14T17:41:51.081Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Brookhaven", + "state": "NY", + "country": "United States", + "classification": "Class II", + "openfda": { + "application_number": [ + "ANDA090576" + ], + "brand_name": [ + "NIZATIDINE" + ], + "generic_name": [ + "NIZATIDINE" + ], + "manufacturer_name": [ + "Amneal Pharmaceuticals LLC" + ], + "product_ndc": [ + "60846-301" + ], + "product_type": [ + "HUMAN PRESCRIPTION DRUG" + ], + "route": [ + "ORAL" + ], + "substance_name": [ + "NIZATIDINE" + ], + "rxcui": [ + "476872" + ], + "spl_id": [ + "aedc4160-2165-451e-8a3b-26d3bb911242" + ], + "spl_set_id": [ + "39e62997-8781-449a-e054-00144ff88e88" + ], + "package_ndc": [ + "60846-301-15" + ], + "is_original_packager": [ + true + ], + "nui": [ + "N0000000151", + "N0000175784" + ], + "pharm_class_moa": [ + "Histamine H2 Receptor Antagonists [MoA]" + ], + "pharm_class_epc": [ + "Histamine-2 Receptor Antagonist [EPC]" + ], + "unii": [ + "P41PML4GHR" + ] + }, + "product_type": "Drugs", + "event_id": "85386", + "recalling_firm": "Amneal Pharmaceuticals of New York, LLC", + "address_1": "50 Horseblock Rd", + "address_2": "N/A", + "postal_code": "11719-9509", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Press Release", + "distribution_pattern": "Nationwide", + "recall_number": "D-1253-2020", + "product_description": "Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15", + "product_quantity": "11258 bottles", + "reason_for_recall": "CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.", + "recall_initiation_date": "20200415", + "center_classification_date": "20200424", + "termination_date": "20210908", + "report_date": "20200506", + "code_info": "06598004A 04/2020 06599001A 12/2020 06599002A 12/2020", + "scrapedAt": "2026-05-14T17:41:51.120Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Lincoln", + "state": "NE", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "65422", + "recalling_firm": "Novartis Consumer Health", + "address_1": "10401 Hwy 6", + "address_2": "N/A", + "postal_code": "68517-9626", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "Nationwide, Puerto Rico, Brazil and Panama", + "recall_number": "D-844-2013", + "product_description": "Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 203 702 Foreign packaging: b) Excedrin Migrana (Acetaminophen 250 mg, Aspirin 250 mg and 65 mg Caffeine) 2-ct pouches. The foreign packaging do not have NDC numbers", + "product_quantity": "10,624,000 pouches", + "reason_for_recall": "Defective container: products are packaged in pouches which may not have been fully sealed", + "recall_initiation_date": "20130606", + "center_classification_date": "20130806", + "termination_date": "20141104", + "report_date": "20130814", + "code_info": "Lot # a) 10116809, Exp 5/13 Foreign: Lot #s b) 10115644 Exp 5/13; 10118226 Exp 5/13; 10118227 Exp 6/13; 10118228 Exp 6/13; 10121956 Exp 8/13 and 10121957 Exp 8/13", + "scrapedAt": "2026-05-14T17:41:51.153Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Toronto", + "state": "", + "country": "Canada", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "70452", + "recalling_firm": "Attix Pharmaceuticals", + "address_1": "184 Front St E", + "address_2": "unit 801", + "postal_code": "N/A", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", + "distribution_pattern": "Nationwide to compounding pharmacies and research organizations.", + "recall_number": "D-707-2015", + "product_description": "Homatropine Methylbromide active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada", + "product_quantity": "940 grams", + "reason_for_recall": "Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.", + "recall_initiation_date": "20141114", + "center_classification_date": "20150420", + "termination_date": "20151007", + "report_date": "20150429", + "code_info": "All lots repackaged and distributed between 01/05/12 to 02/12/15", + "more_code_info": "", + "scrapedAt": "2026-05-14T17:41:51.192Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Bolingbroke", + "state": "GA", + "country": "United States", + "classification": "Class I", + "openfda": {}, + "product_type": "Drugs", + "event_id": "86270", + "recalling_firm": "SG24 LLC", + "address_1": "8315 Rivoli Road", + "address_2": "Ste A", + "postal_code": "31004", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Press Release", + "distribution_pattern": "Nationwide", + "recall_number": "D-1572-2020", + "product_description": "SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147125", + "product_quantity": "9600 bottles", + "reason_for_recall": "Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug", + "recall_initiation_date": "20200814", + "center_classification_date": "20200911", + "termination_date": "20230605", + "report_date": "20200909", + "code_info": "SKU 051230024 All lots labeled to contain methanol", + "scrapedAt": "2026-05-14T17:41:51.224Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Houston", + "state": "TX", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "82941", + "recalling_firm": "Pharm D Solutions, LLC", + "address_1": "1304 S Loop W", + "address_2": "N/A", + "postal_code": "77054-4010", + "voluntary_mandated": "FDA Mandated", + "initial_firm_notification": "Press Release", + "distribution_pattern": "Nationwide within the United States", + "recall_number": "D-1325-2019", + "product_description": "Human Chorionic Gonadotropin 5,000 IU vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846", + "product_quantity": "279 vials", + "reason_for_recall": "Lack of Sterility Assurance.", + "recall_initiation_date": "20190523", + "center_classification_date": "20190607", + "termination_date": "20210205", + "report_date": "20190619", + "code_info": "Lot #: 01082019:88 Exp. 07/06/2019; 03182019:58 Exp. 09/14/2019", + "scrapedAt": "2026-05-14T17:41:51.270Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Ongoing", + "city": "Hattiesburg", + "state": "MS", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "90982", + "recalling_firm": "Pharmacy Plus, Inc. dba Vital Care Compounder", + "address_1": "115 S 40th Ave", + "address_2": "N/A", + "postal_code": "39402-6600", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Telephone", + "distribution_pattern": "AL, LA, MS, and TN", + "recall_number": "D-0037-2023", + "product_description": "MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402", + "product_quantity": "40 vials", + "reason_for_recall": "Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.", + "recall_initiation_date": "20221007", + "center_classification_date": "20221102", + "report_date": "20221109", + "code_info": "Lot: 55786, BUD: 12/31/2022", + "scrapedAt": "2026-05-14T17:41:51.323Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Norwalk", + "state": "CT", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "91719", + "recalling_firm": "Ecometics, Inc.", + "address_1": "19 Concord St", + "address_2": "", + "postal_code": "06854-3706", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "Nationwide within the United States", + "recall_number": "D-0452-2023", + "product_description": "Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%), packaged in 1 oz. (28.3g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756", + "product_quantity": "", + "reason_for_recall": "CGMP DEVIATIONS", + "recall_initiation_date": "20230224", + "center_classification_date": "20230308", + "termination_date": "20230621", + "report_date": "20230315", + "code_info": "Lot #: 1E346A, Exp. Date Nov-23; 2E304A, Exp. Date Oct-24", + "more_code_info": "", + "scrapedAt": "2026-05-14T17:41:51.362Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Ongoing", + "city": "Parsippany", + "state": "NJ", + "country": "United States", + "classification": "Class III", + "openfda": { + "application_number": [ + "ANDA072695" + ], + "brand_name": [ + "NORTREL" + ], + "generic_name": [ + "NORETHINDRONE AND ETHINYL ESTRADIOL" + ], + "manufacturer_name": [ + "Teva Pharmaceuticals USA, Inc." + ], + "product_ndc": [ + "0555-9008", + "0555-9009", + "0555-9010" + ], + "product_type": [ + "HUMAN PRESCRIPTION DRUG" + ], + "rxcui": [ + "310463", + "312033", + "748797", + "749858", + "749869", + "749879", + "751868", + "751870", + "751871" + ], + "spl_id": [ + "9ac007e4-792d-4122-8daf-456dea28f82f" + ], + "spl_set_id": [ + "140c50d6-c931-423a-9aa0-526eae7ab93c" + ], + "package_ndc": [ + "0555-9009-80", + "0555-9009-42", + "0555-9010-79", + "0555-9010-58", + "0555-9008-79", + "0555-9008-67" + ], + "is_original_packager": [ + true + ], + "nui": [ + "N0000175825", + "N0000000100", + "M0447349", + "N0000175602" + ], + "pharm_class_epc": [ + "Estrogen [EPC]", + "Progestin [EPC]" + ], + "pharm_class_moa": [ + "Estrogen Receptor Agonists [MoA]" + ], + "pharm_class_cs": [ + "Progesterone Congeners [CS]" + ], + "unii": [ + "423D2T571U", + "T18F433X4S" + ] + }, + "product_type": "Drugs", + "event_id": "93867", + "recalling_firm": "Teva Pharmaceuticals USA, Inc", + "address_1": "400 Interpace Pkwy Bldg A", + "address_2": "N/A", + "postal_code": "07054-1120", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "nationwide", + "recall_number": "D-0321-2024", + "product_description": "Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67", + "product_quantity": "12,916 cartons", + "reason_for_recall": "Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.", + "recall_initiation_date": "20240125", + "center_classification_date": "20240212", + "report_date": "20240221", + "code_info": "Lot #: 100042978, Exp 7/31/2024", + "scrapedAt": "2026-05-14T17:41:51.398Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Toronto", + "state": "", + "country": "Canada", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "70452", + "recalling_firm": "Attix Pharmaceuticals", + "address_1": "184 Front St E", + "address_2": "unit 801", + "postal_code": "N/A", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", + "distribution_pattern": "Nationwide to compounding pharmacies and research organizations.", + "recall_number": "D-790-2015", + "product_description": "Methyl Folate Calcium active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada", + "product_quantity": "5 grams", + "reason_for_recall": "Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.", + "recall_initiation_date": "20141114", + "center_classification_date": "20150420", + "termination_date": "20151007", + "report_date": "20150429", + "code_info": "All lots repackaged and distributed between 01/05/12 to 02/12/15", + "more_code_info": "", + "scrapedAt": "2026-05-14T17:41:51.456Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Ongoing", + "city": "Bengaluru", + "state": "N/A", + "country": "India", + "classification": "Class II", + "openfda": { + "application_number": [ + "ANDA209101" + ], + "brand_name": [ + "HALOPERIDOL DECANOATE" + ], + "generic_name": [ + "HALOPERIDOL DECANOATE" + ], + "manufacturer_name": [ + "BluePoint Laboratories" + ], + "product_ndc": [ + "68001-578", + "68001-579", + "68001-580", + "68001-581", + "68001-582" + ], + "product_type": [ + "HUMAN PRESCRIPTION DRUG" + ], + "route": [ + "INTRAMUSCULAR" + ], + "substance_name": [ + "HALOPERIDOL DECANOATE" + ], + "rxcui": [ + "859871", + "1719803", + "1719862" + ], + "spl_id": [ + "048557ea-f859-f0f2-e063-6294a90af5ab" + ], + "spl_set_id": [ + "f2d14406-2ad4-4c5b-9c24-a026f27b415d" + ], + "package_ndc": [ + "68001-579-59", + "68001-579-48", + "68001-580-41", + "68001-581-41", + "68001-581-48", + "68001-581-82", + "68001-578-59", + "68001-578-48", + "68001-582-41" + ], + "is_original_packager": [ + true + ], + "upc": [ + "0368001578592", + "0368001581417", + "0368001579599", + "0368001582414" + ], + "unii": [ + "AC20PJ4101" + ] + }, + "product_type": "Drugs", + "event_id": "96569", + "recalling_firm": "Somerset Therapeutics Private Limited", + "address_1": "54/1 Budihal Village", + "address_2": "N/A", + "postal_code": "N/A", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "U.S. Nationwide", + "recall_number": "D-0356-2025", + "product_description": "Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41", + "product_quantity": "4956 vials", + "reason_for_recall": "Lack of Assurance of Sterility: Media fill with bacterial contamination", + "recall_initiation_date": "20250321", + "center_classification_date": "20250408", + "report_date": "20250416", + "code_info": "A240467B, exp. date 07/2026", + "scrapedAt": "2026-05-14T17:41:51.500Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Los Angeles", + "state": "CA", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "84978", + "recalling_firm": "Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical", + "address_1": "1990 Westwood Blvd Ste 135", + "address_2": "N/A", + "postal_code": "90025-4650", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Press Release", + "distribution_pattern": "U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic", + "recall_number": "D-0960-2020", + "product_description": "Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-060-3", + "product_quantity": "N/A", + "reason_for_recall": "Lack of Assurance of Sterility", + "recall_initiation_date": "20200115", + "center_classification_date": "20200305", + "termination_date": "20231207", + "report_date": "20200311", + "code_info": "Lot #: 10152019+53126, Exp 4/6/2020", + "scrapedAt": "2026-05-14T17:41:51.543Z" + }, + { + "_dataset": "drug/enforcement", + "country": "United States", + "city": "Parsippany", + "address_1": "400 Interpace Pkwy", + "reason_for_recall": "CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.", + "address_2": "", + "product_quantity": "2,924,000 tablets", + "code_info": "Arrow Malta (Teva) Bulk Product Lot # 1169752A, exp. date 01/2020, 1000 tablets/bottle 1169753A, exp. date 01/2020, 90 tablets/bottle Golden State Medical Finished Product Lot # GS017387, exp. date 01/2020 GS017651, exp. date 01/2020 GS017479, exp. date 01/2020", + "center_classification_date": "20190709", + "distribution_pattern": "Nationwide by 4 major distributors.", + "state": "NJ", + "product_description": "LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00", + "report_date": "20190717", + "classification": "Class II", + "openfda": {}, + "recalling_firm": "Teva Pharmaceuticals USA", + "recall_number": "D-1455-2019", + "initial_firm_notification": "E-Mail", + "product_type": "Drugs", + "event_id": "83050", + "more_code_info": "", + "recall_initiation_date": "20190606", + "postal_code": "07054-1120", + "voluntary_mandated": "Voluntary: Firm initiated", + "status": "Ongoing", + "scrapedAt": "2026-05-14T17:41:51.584Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Boca Raton", + "state": "FL", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "78553", + "recalling_firm": "KRS Global Biotechnology, Inc", + "address_1": "791 Park of Commerce Blvd Ste 600", + "address_2": "N/A", + "postal_code": "33487-3633", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "Nationwide in the USA, Bermuda, and New Zealand", + "recall_number": "D-0165-2018", + "product_description": "Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.", + "product_quantity": "4,530 jars", + "reason_for_recall": "Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.", + "recall_initiation_date": "20171116", + "center_classification_date": "20180108", + "termination_date": "20200511", + "report_date": "20180117", + "code_info": "Lots: 06072017@22 BUD: 12/4/2017; 06222017@30 BUD: 12/19/2017; 08032017@31 BUD: 1/30/2018; 09212017@21 BUD: 3/20/2018; 10232017@20 BUD: 11/22/2017", + "more_code_info": "", + "scrapedAt": "2026-05-14T17:41:51.622Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "IRVING", + "state": "TX", + "country": "United States", + "classification": "Class II", + "openfda": { + "application_number": [ + "NDA216632" + ], + "brand_name": [ + "CABTREO" + ], + "generic_name": [ + "CLINDAMYCIN PHOSPHATE/BENZOYL PEROXIDE/ADAPALENE" + ], + "manufacturer_name": [ + "Bausch Health US LLC" + ], + "product_ndc": [ + "0187-0006" + ], + "product_type": [ + "HUMAN PRESCRIPTION DRUG" + ], + "route": [ + "TOPICAL" + ], + "substance_name": [ + "ADAPALENE", + "BENZOYL PEROXIDE", + "CLINDAMYCIN PHOSPHATE" + ], + "rxcui": [ + "2668198", + "2668204" + ], + "spl_id": [ + "338bc721-434d-cbc2-e063-6394a90abc47" + ], + "spl_set_id": [ + "9468da0f-9978-4c58-8135-0274c3415084" + ], + "package_ndc": [ + "0187-0006-10", + "0187-0006-25", + "0187-0006-35" + ], + "is_original_packager": [ + true + ], + "nui": [ + "N0000175607", + "M0018962" + ], + "pharm_class_epc": [ + "Retinoid [EPC]" + ], + "pharm_class_cs": [ + "Retinoids [CS]" + ], + "unii": [ + "1L4806J2QF", + "W9WZN9A0GM", + "EH6D7113I8" + ] + }, + "product_type": "Drugs", + "event_id": "94023", + "recalling_firm": "MCKESSON CORPORATION", + "address_1": "6555 NORTH STATE HIGHWA", + "address_2": "N/A", + "postal_code": "75039", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "E-Mail", + "distribution_pattern": "Nationwide in the US", + "recall_number": "D-0347-2024", + "product_description": "CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Bridgewater, NJ 08807 USA, Manufactured by: Bausch Health Companies, Inc. Laval Quebec H7L 448, Canada, NDC 0187-0006-25.", + "product_quantity": "42 units", + "reason_for_recall": "CGMP Deviations: Product was stored outside labeled storage temperature requirements. 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Raleigh, NC 27612.", + "product_quantity": "96 cartons", + "reason_for_recall": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.", + "recall_initiation_date": "20210315", + "center_classification_date": "20210524", + "termination_date": "20240617", + "report_date": "20210602", + "code_info": "37674B", + "scrapedAt": "2026-05-14T17:41:52.371Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Waterford", + "state": "MI", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "79149", + "recalling_firm": "American Pharmaceutical Ingredients LLC", + "address_1": "6650 Highland Rd Ste 302", + "address_2": "N/A", + "postal_code": "48327-1665", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "Nationwide within USA.", + "recall_number": "D-0513-2018", + "product_description": "Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); c) 100g (NDC 58597-8025-6); d) 500g (NDC 58597-8025-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327", + "product_quantity": "44500 g", + "reason_for_recall": "CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.", + "recall_initiation_date": "20180209", + "center_classification_date": "20180222", + "termination_date": "20191202", + "report_date": "20180228", + "code_info": "Lot #: a) 020615-2, Exp. 12/04/2018; b) 020615-2, Exp. 12/04/2018; c) 020615-1, Exp. 12/04/2018; d) 020615-1, Exp. 12/04/2018; 020615-2, Exp. 12/04/2018.", + "scrapedAt": "2026-05-14T17:41:52.403Z" + }, + { + "_dataset": "drug/enforcement", + "country": "United States", + "city": "Vancouver", + "address_1": "14301 Se 1st St", + "reason_for_recall": "Labeling: Label Mixup: FLUCONAZOLE, Tablet, 200 mg may have potentially been mislabeled as one of the following drugs: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD65475_10, EXP: 5/28/2014; FLUCONAZOLE, Tablet, 100 mg, NDC 68462010230, Pedigree: W003064, EXP: 6/12/2014.", + "address_2": "", + "product_quantity": "200 Tablets", + "code_info": "FLUCONAZOLE, Tablet, 200 mg has the following codes: Pedigree: AD65475_16, EXP: 5/28/2014; Pedigree: W003065, EXP: 6/12/2014.", + "center_classification_date": "20140120", + "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", + "state": "WA", + "product_description": "FLUCONAZOLE, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00172541360.", + "report_date": "20140129", + "classification": "Class II", + "openfda": {}, + "recalling_firm": "Aidapak Services, LLC", + "recall_number": "D-871-2014", + "initial_firm_notification": "Telephone", + "product_type": "Drugs", + "event_id": "65690", + "termination_date": "20140207", + "more_code_info": "", + "recall_initiation_date": "20130702", + "postal_code": "98684-3501", + "voluntary_mandated": "Voluntary: Firm initiated", + "status": "Terminated", + "scrapedAt": "2026-05-14T17:41:52.441Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Baltimore", + "state": "MD", + "country": "United States", + "classification": "Class II", + "openfda": { + "application_number": [ + "ANDA065259" + ], + "brand_name": [ + "CEFDINIR" + ], + "generic_name": [ + "CEFDINIR" + ], + "manufacturer_name": [ + "Lupin Pharmaceuticals, Inc." + ], + "product_ndc": [ + "68180-722", + "68180-723" + ], + "product_type": [ + "HUMAN PRESCRIPTION DRUG" + ], + "route": [ + "ORAL" + ], + "substance_name": [ + "CEFDINIR" + ], + "rxcui": [ + "309054", + "476576" + ], + "spl_id": [ + "b32b7bfb-4770-4da0-8c48-684233cd10c9" + ], + "spl_set_id": [ + "7490df67-56c0-4a1c-8533-2107f3e8aea5" + ], + "package_ndc": [ + "68180-722-20", + "68180-722-10", + "68180-722-04", + "68180-722-05", + "68180-723-20", + "68180-723-10", + "68180-723-04", + "68180-723-05" + ], + "is_original_packager": [ + true + ], + "upc": [ + "0368180723042" + ], + "nui": [ + "N0000175488", + "M0003827" + ], + "pharm_class_epc": [ + "Cephalosporin Antibacterial [EPC]" + ], + "pharm_class_cs": [ + "Cephalosporins [CS]" + ], + "unii": [ + "CI0FAO63WC" + ] + }, + "product_type": "Drugs", + "event_id": "81888", + "recalling_firm": "Lupin Pharmaceuticals Inc.", + "address_1": "111 S Calvert St Fl 21ST", + "address_2": "", + "postal_code": "21202-6174", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "Nationwide within the United States", + "recall_number": "D-0375-2019", + "product_description": "Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA", + "product_quantity": "287,784 bottles", + "reason_for_recall": "CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.", + "recall_initiation_date": "20190102", + "center_classification_date": "20190115", + "termination_date": "20200626", + "report_date": "20190116", + "code_info": "a) Lot #: F700329, F700330, F700328, Exp. January 2019; F700544, F700545, F700668, F700669, F700670, Exp. March 2019; F700958, Exp. April 2019 b) Lot #: F700327, F700392, F700393, Exp. January 2019; F700546, F700547, F700664, Exp. March 2019; F700967, Exp. April 2019, F701106, F701107, F701108, F701109, Exp. 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lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot", + "recall_initiation_date": "20130520", + "center_classification_date": "20130807", + "termination_date": "20141028", + "report_date": "20130814", + "code_info": "Lot 25394DK, exp. 01/2015", + "scrapedAt": "2026-05-14T17:41:52.510Z" + }, + { + "_dataset": "drug/enforcement", + "country": "United States", + "city": "Houston", + "address_1": "9265 Kirby Dr", + "reason_for_recall": "Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.", + "address_2": "", + "product_quantity": "", + "code_info": "all lots within expiry", + "center_classification_date": "20170523", + "distribution_pattern": "U.S. Nationwide", + "state": "TX", + "product_description": "Succinylcholine Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054", + "report_date": "20170531", + "classification": "Class II", + "openfda": {}, + "recalling_firm": "Advanced Pharma Inc.", + "recall_number": "D-0831-2017", + "initial_firm_notification": "E-Mail", + "product_type": "Drugs", + "event_id": "76561", + "termination_date": "20171018", + "more_code_info": "", + "recall_initiation_date": "20170222", + "postal_code": "77054-2520", + "voluntary_mandated": "Voluntary: Firm initiated", + "status": "Terminated", + "scrapedAt": "2026-05-14T17:41:52.546Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Newbern", + "state": "TN", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "65479", + "recalling_firm": "Main Street Family Pharmacy, LLC", + "address_1": "126 East Main Street", + "address_2": "N/A", + "postal_code": "38059", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Telephone", + "distribution_pattern": "nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV", + "recall_number": "D-241-2014", + "product_description": "Mic Ultra-Sulfur Free 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200", + "product_quantity": "115 units", + "reason_for_recall": "The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.", + "recall_initiation_date": "20130528", + "center_classification_date": "20131203", + "termination_date": "20140422", + "report_date": "20131211", + "code_info": "all codes distributed prior to and including 05/23/2013", + "scrapedAt": "2026-05-14T17:41:52.576Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Aurora", + "state": "IL", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "71535", + "recalling_firm": "the Compounder", + "address_1": "340 Marshall Ave Unit 100", + "address_2": "N/A", + "postal_code": "60506-5649", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Telephone", + "distribution_pattern": "Nationwide", + "recall_number": "D-0204-2016", + "product_description": "BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) : DHEA (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 2.5 : 17.5 : 1.25 :0.25MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.", + "product_quantity": "12 (10mL) syringes", + "reason_for_recall": "Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.", + "recall_initiation_date": "20150310", + "center_classification_date": "20151110", + "termination_date": "20160519", + "report_date": "20151118", + "code_info": "Lot # 01152015:68@24, Exp 7/14/2015; and Lot # 02192015:15@12, Exp 8/18/2015", + "scrapedAt": "2026-05-14T17:41:52.618Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Ongoing", + "city": "East Brunswick", + "state": "NJ", + "country": "United States", + "classification": "Class II", + "openfda": { + "application_number": [ + "ANDA079106" + ], + "brand_name": [ + "BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE" + ], + "generic_name": [ + "BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE" + ], + "manufacturer_name": [ + "Unichem Pharmaceuticals (USA), Inc." + ], + "product_ndc": [ + "29300-187", + "29300-188", + "29300-189" + ], + "product_type": [ + "HUMAN PRESCRIPTION DRUG" + ], + "route": [ + "ORAL" + ], + "substance_name": [ + "BISOPROLOL FUMARATE", + "HYDROCHLOROTHIAZIDE" + ], + "rxcui": [ + "854908", + "854916", + "854919" + ], + "spl_id": [ + "057844aa-5d7e-4e83-b71f-9072d2a2b93d" + ], + "spl_set_id": [ + "b9ee689a-ea12-435d-b01c-70d45891e62f" + ], + "package_ndc": [ + "29300-187-13", + "29300-187-01", + "29300-187-05", + "29300-187-10", + "29300-188-13", + "29300-188-01", + "29300-188-05", + "29300-188-10", + "29300-189-13", + "29300-189-01", + "29300-189-05", + "29300-189-10" + ], + "is_original_packager": [ + true + ], + "nui": [ + "N0000175359", + "N0000175419", + "M0471776" + ], + "pharm_class_pe": [ + "Increased Diuresis [PE]" + ], + "pharm_class_epc": [ + "Thiazide Diuretic [EPC]" + ], + "pharm_class_cs": [ + "Thiazides [CS]" + ], + "unii": [ + "UR59KN573L", + "0J48LPH2TH" + ] + }, + "product_type": "Drugs", + "event_id": "98323", + "recalling_firm": "Unichem Pharmaceuticals USA Inc.", + "address_1": "1 Tower Center Blvd Ste 2200", + "address_2": "N/A", + "postal_code": "08816-1145", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "US Nationwide and PR.", + "recall_number": "D-0301-2026", + "product_description": "Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. 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Date 01/31/2026", + "more_code_info": "", + "scrapedAt": "2026-05-14T17:41:52.741Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Chattanooga", + "state": "TN", + "country": "United States", + "classification": "Class I", + "openfda": {}, + "product_type": "Drugs", + "event_id": "89138", + "recalling_firm": "Aroma Release Technologies Inc", + "address_1": "7026 Discovery Dr", + "address_2": "", + "postal_code": "37416-1692", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "Distributed in the states of Texas and New York.", + "recall_number": "D-0298-2022", + "product_description": "Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Technology, Inc., 7026 Discovery Drive, Chattanooga, TN 37416", + "product_quantity": "37 55-gallon drums", + "reason_for_recall": "Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol", + "recall_initiation_date": "20211130", + "center_classification_date": "20211228", + "termination_date": "20240315", + "report_date": "20220105", + "code_info": "Lots: 1620-1, 1620-3, 1620-4, 1820-4, 1820-5, 1920-1, 1920-2, No Expiration Date", + "more_code_info": "", + "scrapedAt": "2026-05-14T17:41:52.780Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Ongoing", + "city": "Fair Lawn", + "state": "NJ", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "91427", + "recalling_firm": "Fisher Scientific Co., LLC", + "address_1": "1 Reagent Ln", + "address_2": "N/A", + "postal_code": "07410-2802", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", + "distribution_pattern": "Nationwide in the USA", + "recall_number": "D-0163-2023", + "product_description": "Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.", + "product_quantity": "a) 1077 bottles, b) 52 cases", + "reason_for_recall": "CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.", + "recall_initiation_date": "20230117", + "center_classification_date": "20230118", + "report_date": "20230125", + "code_info": "Lot Numbers: 202160, 202162, 202324, 202368, 202369, 202593, 202594, 202835, 202862, 202863, 202865, 202836, 202864, 203061, 203098, 203099, 203100, 203101, 203102, 203236, 203237, 203239, 203337, 203338, 203335, 203336", + "scrapedAt": "2026-05-14T17:41:52.825Z" + }, + { + "_dataset": "drug/enforcement", + "country": "United States", + "city": "Vancouver", + "address_1": "14301 Se 1st St", + "reason_for_recall": "Labeling:Label Mixup; VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: AD73652_10, EXP: 5/30/2014; HYOSCYAMINE SULFATE ER, Tablet, 0.375 mg, NDC 43199001401, Pedigree: W003576, EXP: 6/24/2014; MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD70655_14, EXP: 5/28/2014; MELATONIN, Tablet, 3 mg, NDC", + "address_2": "", + "product_quantity": "600 Tablets", + "code_info": "VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet has the following codes Pedigree: AD73652_19, EXP: 5/30/2014; Pedigree: W003591, EXP: 6/24/2014; Pedigree: AD70655_17, EXP: 5/28/2014; Pedigree: W003361, EXP: 6/19/2014.", + "center_classification_date": "20140116", + "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", + "state": "WA", + "product_description": "VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258016001", + "report_date": "20140122", + "classification": "Class II", + "openfda": {}, + "recalling_firm": "Aidapak Services, LLC", + "recall_number": "D-653-2014", + "initial_firm_notification": "Telephone", + "product_type": "Drugs", + "event_id": "65707", + "termination_date": "20140207", + "more_code_info": "", + "recall_initiation_date": "20130702", + "postal_code": "98684-3501", + "voluntary_mandated": "Voluntary: Firm initiated", + "status": "Terminated", + "scrapedAt": "2026-05-14T17:41:52.846Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Monterey Park", + "state": "CA", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "83437", + "recalling_firm": "Herbal Doctor Remedies", + "address_1": "497 Cumbre St", + "address_2": "N/A", + "postal_code": "91754-2114", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "N/A", + "distribution_pattern": "Nationwide within the United States and Brazil and on the internet", + "recall_number": "D-1613-2019", + "product_description": "Prostatin Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808", + "product_quantity": "N/A", + "reason_for_recall": "CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.", + "recall_initiation_date": "20190712", + "center_classification_date": "20190802", + "termination_date": "20230613", + "report_date": "20190814", + "code_info": "All lots within expiry", + "scrapedAt": "2026-05-14T17:41:52.889Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "San Antonio", + "state": "TX", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "88862", + "recalling_firm": "Vita Pharmacy, LLC dba Talon Compounding Pharmacy", + "address_1": "2950 Thousand Oaks Dr Ste 25", + "address_2": "N/A", + "postal_code": "78247-3347", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Telephone", + "distribution_pattern": "United States including Washington, D.C. and Puerto Rico", + "recall_number": "D-0106-2022", + "product_description": "B COMPLEX INJ CMP-NO B12, NO LIDOCAINE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247", + "product_quantity": "1 vial", + "reason_for_recall": "Lack of assurance of sterility", + "recall_initiation_date": "20211012", + "center_classification_date": "20211108", + "termination_date": "20231004", + "report_date": "20211117", + "code_info": "Lot: 07192021:91 BUD: 10/17/2021", + "more_code_info": "", + "scrapedAt": "2026-05-14T17:41:52.908Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Asheville", + "state": "NC", + "country": "United States", + "classification": "Class I", + "openfda": {}, + "product_type": "Drugs", + "event_id": "80601", + "recalling_firm": "King Bio Inc.", + "address_1": "3 Westside Dr", + "address_2": "N/A", + "postal_code": "28806-2846", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Press Release", + "distribution_pattern": "U.S.A. 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Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-943-11", + "product_quantity": "3,200 bottles", + "reason_for_recall": "Defective Container: Repetitive complaints received indicating pump not working.", + "recall_initiation_date": "20190313", + "center_classification_date": "20190319", + "termination_date": "20200626", + "report_date": "20190327", + "code_info": "Lot # K700086, Exp 11/2019", + "scrapedAt": "2026-05-14T17:41:53.028Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Plattsburgh", + "state": "NY", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "90653", + "recalling_firm": "SterRx, LLC", + "address_1": "141 Idaho Ave", + "address_2": "", + "postal_code": "12903-3987", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "Nationwide within the United States", + "recall_number": "D-1332-2022", + "product_description": "fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02.", + "product_quantity": "360 bags", + "reason_for_recall": "Lack of Assurance of Sterility", + "recall_initiation_date": "20220725", + "center_classification_date": "20220809", + "termination_date": "20230622", + "report_date": "20220817", + "code_info": "Lot #: CHL, Exp. 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Devon Ave., Chicago, IL 60659, 1 (877) BELLA.", + "product_quantity": "5 vials", + "reason_for_recall": "Lack of Assurance of Sterility.", + "recall_initiation_date": "20170815", + "center_classification_date": "20170912", + "termination_date": "20180423", + "report_date": "20170920", + "code_info": "Lot #: BPLG08517, Exp. 2/5/18", + "scrapedAt": "2026-05-14T17:41:53.270Z" + }, + { + "_dataset": "drug/enforcement", + "country": "United States", + "city": "Staten Island", + "address_1": "119 Linwood Ave", + "reason_for_recall": "Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.", + "address_2": "", + "product_quantity": "unknown", + "code_info": "All Lots", + "center_classification_date": "20180228", + "distribution_pattern": "NY and NJ through six retail stores named \"Asian Food Markets\"", + "state": "NY", + "product_description": "Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language", + "report_date": "20180207", + "classification": "Class I", + "openfda": {}, + "recalling_firm": "A&H Focal Inc.", + "recall_number": "D-0563-2018", + "initial_firm_notification": "Press Release", + "product_type": "Drugs", + "event_id": "76644", + "termination_date": "20190614", + "more_code_info": "", + "recall_initiation_date": "20170307", + "postal_code": "10305-4445", + "voluntary_mandated": "Voluntary: Firm initiated", + "status": "Terminated", + "scrapedAt": "2026-05-14T17:41:53.290Z" + }, + { + "_dataset": "drug/enforcement", + "country": "United States", + "city": "Lake Mary", + "address_1": "550 Technology Park Ste 1008", + "reason_for_recall": "Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.", + "address_2": "", + "product_quantity": "61 vials (5 mL and 10 mL vials)", + "code_info": "ALL Lots", + "center_classification_date": "20130423", + "distribution_pattern": "CO, GA, MI, and Puerto Rico", + "state": "FL", + "product_description": "Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746", + "report_date": "20130501", + "classification": "Class II", + "openfda": {}, + "recalling_firm": "Axium Healthcare Pharmacy dba Balanced Solutions Compounding", + "recall_number": "D-282-2013", + "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", + "product_type": "Drugs", + "event_id": "64957", + "termination_date": "20170419", + "more_code_info": "", + "recall_initiation_date": "20130417", + "postal_code": "32746-7131", + "voluntary_mandated": "Voluntary: Firm initiated", + "status": "Terminated", + "scrapedAt": "2026-05-14T17:41:53.312Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Chicago", + "state": "IL", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "77959", + "recalling_firm": "Bella Pharmaceuticals, Inc.", + "address_1": "3101 W Devon Ave", + "address_2": "N/A", + "postal_code": "60659-1407", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Telephone", + "distribution_pattern": "Nationwide within USA", + "recall_number": "D-1152-2017", + "product_description": "Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. 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"Letter", + "distribution_pattern": "Product was distributed nationwide by three major distributors who may have further distributed the product.", + "recall_number": "D-1842-2019", + "product_description": "Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. 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Also packaged under foreign labels: Theraflu Extra Cold and Flu powder packets, Lemon flavor, 10-count packets per box, UPC 4 607045 191395 (Russia and Former Soviet Union product); Theraflu Nighttime Severe Cold powder packets, Natural Lemon flavor, 6-count packets per carton, Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, UPC 8 806536 013925 (Korea product);", + "report_date": "20140129", + "classification": "Class II", + "openfda": {}, + "recalling_firm": "Novartis Consumer Health", + "recall_number": "D-759-2014", + "initial_firm_notification": "Letter", + "product_type": "Drugs", + "event_id": "65490", + "termination_date": "20141104", + "more_code_info": "", + "recall_initiation_date": "20130618", + "postal_code": "68517-9626", + "voluntary_mandated": "Voluntary: Firm initiated", + "status": "Terminated", + "scrapedAt": "2026-05-14T17:41:53.521Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "Monterey Park", + "state": "CA", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "85341", + "recalling_firm": "Herbal Doctor Remedies", + "address_1": "497 Cumbre St", + "address_2": "N/A", + "postal_code": "91754-2114", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Other", + "distribution_pattern": "Products are sold online within the United States and internationally to the following countries: Australia, Canada, Israel, Italy, Japan, Norway, and United Kingdom", + "recall_number": "D-1122-2020", + "product_description": "Edema Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808", + "product_quantity": "N/A", + "reason_for_recall": "CGMP Deviations: These products have been found to be misbranded as unapproved new drugs", + "recall_initiation_date": "20200324", + "center_classification_date": "20200407", + "termination_date": "20240125", + "report_date": "20200415", + "code_info": "All lots within expiry", + "scrapedAt": "2026-05-14T17:41:53.585Z" + }, + { + "_dataset": "drug/enforcement", + "status": "Terminated", + "city": "La Vergne", + "state": "TN", + "country": "United States", + "classification": "Class II", + "openfda": {}, + "product_type": "Drugs", + "event_id": "92524", + "recalling_firm": "The Harvard Drug Group", + "address_1": "341 Mason Rd", + "address_2": "N/A", + "postal_code": "37086-3606", + "voluntary_mandated": "Voluntary: Firm initiated", + "initial_firm_notification": "Letter", + "distribution_pattern": "Nationwide in the U.S.", + "recall_number": "D-0878-2023", + "product_description": "Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. 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