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{
"_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. De C.V.",
"address_1": "Oriente Cuatro No. 11 Nuevo",
"address_2": "N/A",
"postal_code": "N/A",
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"HUMAN PRESCRIPTION DRUG"
],
"route": [
"SUBCUTANEOUS"
],
"substance_name": [
"ENOXAPARIN SODIUM"
],
"rxcui": [
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"854235",
"854238",
"854241",
"854245",
"854248",
"854252"
],
"spl_id": [
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],
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"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": [
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{
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{
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{
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{
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{
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},
{
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{
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},
{
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],
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],
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],
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],
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],
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],
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]
},
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{
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],
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],
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"ONDANSETRON"
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],
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"0409-4759"
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true
],
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},
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},
{
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"recall_initiation_date": "20170222",
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{
"_dataset": "drug/enforcement",
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"openfda": {},
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"recalling_firm": "Main Street Family Pharmacy, LLC",
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"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",
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"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.",
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{
"_dataset": "drug/enforcement",
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"classification": "Class II",
"openfda": {},
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"recalling_firm": "the Compounder",
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"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.",
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"code_info": "Lot # 01152015:68@24, Exp 7/14/2015; and Lot # 02192015:15@12, Exp 8/18/2015",
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},
{
"_dataset": "drug/enforcement",
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"city": "East Brunswick",
"state": "NJ",
"country": "United States",
"classification": "Class II",
"openfda": {
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"ANDA079106"
],
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"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE"
],
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"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE"
],
"manufacturer_name": [
"Unichem Pharmaceuticals (USA), Inc."
],
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"29300-187",
"29300-188",
"29300-189"
],
"product_type": [
"HUMAN PRESCRIPTION DRUG"
],
"route": [
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],
"substance_name": [
"BISOPROLOL FUMARATE",
"HYDROCHLOROTHIAZIDE"
],
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"854908",
"854916",
"854919"
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"29300-188-13",
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"29300-188-10",
"29300-189-13",
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"is_original_packager": [
true
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"nui": [
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"N0000175419",
"M0471776"
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"pharm_class_pe": [
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],
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"Thiazides [CS]"
],
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"0J48LPH2TH"
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},
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"address_1": "1 Tower Center Blvd Ste 2200",
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},
{
"_dataset": "drug/enforcement",
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"openfda": {},
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"recalling_firm": "SCA Pharmaceuticals",
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"distribution_pattern": "KY and NJ",
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"product_description": "FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40",
"product_quantity": "183 bags",
"reason_for_recall": "cGMP deviations: due to shipment of rejected units.",
"recall_initiation_date": "20230720",
"center_classification_date": "20230726",
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"report_date": "20230802",
"code_info": "Lot # 1223047134, Use By: 09/21/2023",
"scrapedAt": "2026-05-14T17:41:52.684Z"
},
{
"_dataset": "drug/enforcement",
"status": "Terminated",
"city": "South San Francisco",
"state": "CA",
"country": "United States",
"classification": "Class II",
"openfda": {
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"BLA103172"
],
"brand_name": [
"CATHFLO ACTIVASE"
],
"generic_name": [
"ALTEPLASE"
],
"manufacturer_name": [
"Genentech, Inc."
],
"product_ndc": [
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],
"product_type": [
"HUMAN PRESCRIPTION DRUG"
],
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],
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"is_original_packager": [
true
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"unii": [
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},
"product_type": "Drugs",
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"recalling_firm": "Genentech, Inc.",
"address_1": "1 Dna Way Bldg 5",
"address_2": "",
"postal_code": "94080-4918",
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"recall_number": "D-0509-2024",
"product_description": "Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64",
"product_quantity": "Lot:3618858 = 105,759; Lot:3618873 =90,359",
"reason_for_recall": "Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.",
"recall_initiation_date": "20240520",
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"code_info": "Lot #: 3618858, 3618873, Exp. Date 01/31/2026",
"more_code_info": "",
"scrapedAt": "2026-05-14T17:41:52.741Z"
},
{
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"classification": "Class I",
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"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",
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"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",
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"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",
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"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",
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"report_date": "20190814",
"code_info": "All lots within expiry",
"scrapedAt": "2026-05-14T17:41:52.889Z"
},
{
"_dataset": "drug/enforcement",
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"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",
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"city": "Asheville",
"state": "NC",
"country": "United States",
"classification": "Class I",
"openfda": {},
"product_type": "Drugs",
"event_id": "80601",
"recalling_firm": "King Bio Inc.",
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},
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{
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{
"_dataset": "drug/enforcement",
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{
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{
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"address_1": "755 Rainbow Rd Ste B",
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"product_quantity": "5,948 syringes, expanded 2,102 syringes",
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},
{
"_dataset": "drug/enforcement",
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},
{
"_dataset": "drug/enforcement",
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"country": "United States",
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"address_1": "3101 W Devon Ave",
"address_2": "N/A",
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},
{
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"address_2": "",
"product_quantity": "unknown",
"code_info": "All Lots",
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"distribution_pattern": "NY and NJ through six retail stores named \"Asian Food Markets\"",
"state": "NY",
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"recall_initiation_date": "20170307",
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},
{
"_dataset": "drug/enforcement",
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"recall_number": "D-282-2013",
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},
{
"_dataset": "drug/enforcement",
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"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",
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"recall_number": "D-1152-2017",
"product_description": "Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.",
"product_quantity": "7 vials",
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"recall_initiation_date": "20170815",
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"report_date": "20170920",
"code_info": "Lot #: BPMC30072917, Exp. 1/29/18",
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},
{
"_dataset": "drug/enforcement",
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"city": "Ocala",
"state": "FL",
"country": "United States",
"classification": "Class II",
"openfda": {},
"product_type": "Drugs",
"event_id": "75289",
"recalling_firm": "Wells Pharmacy Network LLC",
"address_1": "1210 SW 33rd Ave",
"address_2": "N/A",
"postal_code": "34474-2853",
"voluntary_mandated": "Voluntary: Firm initiated",
"initial_firm_notification": "Press Release",
"distribution_pattern": "Nationwide",
"recall_number": "D-0337-2017",
"product_description": "Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL",
"product_quantity": "a) 24 vials, b) 91 vials",
"reason_for_recall": "Lack of Assurance of Sterility",
"recall_initiation_date": "20160921",
"center_classification_date": "20170104",
"termination_date": "20210702",
"report_date": "20170111",
"code_info": "All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 03312016@6 b) Known lot code: 04222016@8, 15202016@85, 06302016@4, 08012016@32",
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},
{
"_dataset": "drug/enforcement",
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"address_1": "1515 Elizabeth St Ste J",
"reason_for_recall": "Lack of assurance of sterility.",
"address_2": "",
"product_quantity": "",
"code_info": "All lots remaining within expiry.",
"center_classification_date": "20190910",
"distribution_pattern": "Continental U.S. and Puerto Rico",
"state": "FL",
"product_description": "Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901",
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"classification": "Class II",
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"recalling_firm": "Pacifico National, Inc. dba AmEx Pharmacy",
"recall_number": "D-1849-2019",
"initial_firm_notification": "Press Release",
"product_type": "Drugs",
"event_id": "83702",
"termination_date": "20201008",
"more_code_info": "",
"recall_initiation_date": "20190830",
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{
"_dataset": "drug/enforcement",
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"country": "United States",
"classification": "Class II",
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"recalling_firm": "Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy",
"address_1": "996 Nw Circle Blvd Ste 105",
"address_2": "N/A",
"postal_code": "97330-1485",
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"recall_number": "D-1110-2019",
"product_description": "PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.64MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .",
"product_quantity": "1 prescription, 5ml injection",
"reason_for_recall": "Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.",
"recall_initiation_date": "20190221",
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"termination_date": "20200723",
"report_date": "20190417",
"code_info": "Lot:13092018@44, distributed between 09-01-2018 to 02-20-2019.",
"scrapedAt": "2026-05-14T17:41:53.436Z"
},
{
"_dataset": "drug/enforcement",
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"state": "NJ",
"country": "United States",
"classification": "Class III",
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],
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],
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"65862-051",
"65862-052",
"65862-053",
"65862-054"
],
"product_type": [
"HUMAN PRESCRIPTION DRUG"
],
"route": [
"ORAL"
],
"substance_name": [
"SIMVASTATIN"
],
"rxcui": [
"198211",
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"312961",
"312962",
"314231"
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],
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"65862-050-45",
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"65862-053-90",
"65862-053-01",
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"65862-053-99",
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"65862-054-30",
"65862-054-45",
"65862-054-90",
"65862-054-00",
"65862-054-99",
"65862-054-39"
],
"is_original_packager": [
true
],
"nui": [
"N0000175589",
"N0000000121"
],
"pharm_class_epc": [
"HMG-CoA Reductase Inhibitor [EPC]"
],
"pharm_class_moa": [
"Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"
],
"unii": [
"AGG2FN16EV"
]
},
"product_type": "Drugs",
"event_id": "83436",
"recalling_firm": "Aurobindo Pharma USA Inc.",
"address_1": "279 Princeton Hightstown Rd",
"address_2": "N/A",
"postal_code": "08520-1401",
"voluntary_mandated": "Voluntary: Firm initiated",
"initial_firm_notification": "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. Dayton, NJ 08810 NDC 65862-053-99",
"product_quantity": "2,352/1000 count bottles",
"reason_for_recall": "Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B",
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"report_date": "20190904",
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},
{
"_dataset": "drug/enforcement",
"status": "Terminated",
"city": "Brooklyn",
"state": "NY",
"country": "United States",
"classification": "Class II",
"openfda": {},
"product_type": "Drugs",
"event_id": "83136",
"recalling_firm": "Infusion Options, Inc.",
"address_1": "5924 13th Ave",
"address_2": "N/A",
"postal_code": "11219-4934",
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"product_description": "Adcetris 96 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233",
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"code_info": "All lots within expiry",
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},
{
"_dataset": "drug/enforcement",
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"address_1": "10401 Hwy 6",
"reason_for_recall": "Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.",
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"code_info": "Lot #: 10113888, Exp 5/31/2013; 10118944, Exp 6/30/2013; 10120024, Exp 9/30/2013; 10124381, Exp 10/31/2013. Russia product: 10112623, 10112625, 10112627, 10112629, 10112631, 10112633, Exp 5/31/2013; 10116051, 10116053, 10116055, 10116057, 10116059, 10116061,10117302, 10117304, Exp 7/31/2013; 10119732, 10119735, Exp 9/30/2013; 10124276, 10124281, 10125922, 10126539, 10126540, 10126541, 10126542, 10126543, Exp 10/31/2013; Korea product: 10112969, Exp 5/31/2013; 10116034, Exp 7/31/2013; 10120027, Exp 9/30/2013.",
"center_classification_date": "20140117",
"distribution_pattern": "Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.",
"state": "NE",
"product_description": "NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga , ON, UPC 0 58478 05103 1. 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",
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"recalling_firm": "Novartis Consumer Health",
"recall_number": "D-759-2014",
"initial_firm_notification": "Letter",
"product_type": "Drugs",
"event_id": "65490",
"termination_date": "20141104",
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"recall_initiation_date": "20130618",
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"status": "Terminated",
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},
{
"_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",
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"termination_date": "20240125",
"report_date": "20200415",
"code_info": "All lots within expiry",
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},
{
"_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",
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"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. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61",
"product_quantity": "3876 cartons",
"reason_for_recall": "Packaging defect: blister packaging inadequately sealed.",
"recall_initiation_date": "20230616",
"center_classification_date": "20230626",
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"report_date": "20230705",
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},
{
"_dataset": "drug/enforcement",
"status": "Terminated",
"city": "Erie",
"state": "PA",
"country": "United States",
"classification": "Class II",
"openfda": {},
"product_type": "Drugs",
"event_id": "91332",
"recalling_firm": "Pharmacy Innovations",
"address_1": "2936 W 17th St",
"address_2": "N/A",
"postal_code": "16505-3929",
"voluntary_mandated": "Voluntary: Firm initiated",
"initial_firm_notification": "Telephone",
"distribution_pattern": "Nationwide in the USA",
"recall_number": "D-0210-2023",
"product_description": "GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 200MG/ML (1ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 220MG/ML (30ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (1ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (2ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED-PF- 200MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.",
"product_quantity": "N/A",
"reason_for_recall": "Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.",
"recall_initiation_date": "20221222",
"center_classification_date": "20230126",
"termination_date": "20240731",
"report_date": "20230201",
"code_info": "t20221129@68 t20221025@32 t20221025@33 t20221114@27 t20221021@40 t20221116@36",
"more_code_info": "",
"scrapedAt": "2026-05-14T17:41:53.637Z"
},
{
"_dataset": "drug/enforcement",
"status": "Terminated",
"city": "Parsippany",
"state": "NJ",
"country": "United States",
"classification": "Class II",
"openfda": {
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"ANDA201089"
],
"brand_name": [
"DICLOFENAC SODIUM AND MISOPROSTOL"
],
"generic_name": [
"DICLOFENAC SODIUM AND MISOPROSTOL"
],
"manufacturer_name": [
"Actavis Pharma, Inc."
],
"product_ndc": [
"0591-0397",
"0591-0398"
],
"product_type": [
"HUMAN PRESCRIPTION DRUG"
],
"route": [
"ORAL"
],
"substance_name": [
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"MISOPROSTOL"
],
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"857706",
"1359105"
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],
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"0591-0397-19",
"0591-0398-60"
],
"is_original_packager": [
true
],
"nui": [
"N0000175785",
"M0017811"
],
"pharm_class_epc": [
"Prostaglandin E1 Analog [EPC]"
],
"pharm_class_cs": [
"Prostaglandins E, Synthetic [CS]"
],
"unii": [
"0E43V0BB57",
"QTG126297Q"
]
},
"product_type": "Drugs",
"event_id": "66380",
"recalling_firm": "Actavis Inc",
"address_1": "400 Interpace Pkwy",
"address_2": "",
"postal_code": "07054-1120",
"voluntary_mandated": "Voluntary: Firm initiated",
"initial_firm_notification": "Letter",
"distribution_pattern": "Nationwide",
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"product_description": "Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles)",
"product_quantity": "6,540 bottles",
"reason_for_recall": "Failed Tablet/Capsule Specifications: Broken tablets",
"recall_initiation_date": "20130322",
"center_classification_date": "20140203",
"termination_date": "20150226",
"report_date": "20140212",
"code_info": "Lot 668271A, Exp 11/14 and Lot 684119A Exp 01/2015",
"more_code_info": "",
"scrapedAt": "2026-05-14T17:41:53.661Z"
},
{
"_dataset": "drug/enforcement",
"status": "Ongoing",
"city": "Mahwah",
"state": "NJ",
"country": "United States",
"classification": "Class II",
"openfda": {
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"ANDA078427"
],
"brand_name": [
"CETIRIZINE HCL"
],
"generic_name": [
"CETIRIZINE"
],
"manufacturer_name": [
"GLENMARK THERAPEUTICS INC., USA"
],
"product_ndc": [
"72657-128",
"72657-129",
"72657-130",
"72657-131"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"ORAL"
],
"substance_name": [
"CETIRIZINE HYDROCHLORIDE"
],
"rxcui": [
"1014676",
"1014678"
],
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],
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"package_ndc": [
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"72657-128-45",
"72657-128-60",
"72657-128-70",
"72657-128-90",
"72657-128-08",
"72657-128-14",
"72657-128-15",
"72657-128-18",
"72657-128-24",
"72657-128-03",
"72657-128-35",
"72657-128-04",
"72657-128-81",
"72657-128-82",
"72657-128-84",
"72657-128-86",
"72657-128-41",
"72657-129-30",
"72657-129-45",
"72657-129-60",
"72657-129-70",
"72657-129-90",
"72657-129-08",
"72657-129-14",
"72657-129-15",
"72657-129-18",
"72657-129-24",
"72657-129-03",
"72657-129-35",
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"72657-129-81",
"72657-129-82",
"72657-129-84",
"72657-129-86",
"72657-129-41",
"72657-130-05",
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"is_original_packager": [
true
],
"upc": [
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"0372657129350"
],
"unii": [
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]
},
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"event_id": "96474",
"recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
"address_1": "750 Corporate Dr",
"address_2": "N/A",
"postal_code": "07430-2009",
"voluntary_mandated": "Voluntary: Firm initiated",
"initial_firm_notification": "Letter",
"distribution_pattern": "U.S. Nationwide",
"recall_number": "D-0348-2025",
"product_description": "Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35",
"product_quantity": "N/A",
"reason_for_recall": "CGMP Deviations",
"recall_initiation_date": "20250313",
"center_classification_date": "20250408",
"report_date": "20250416",
"code_info": "Lot # 17231980, ep.. date Aug-25 Amazon 17232044, ep.. date Aug-25 Walmart 17241436, ep.. date Jul-26 Amazon 17241437, ep.. date Jul-26 Amazon 17241455, ep.. date Jul-26 Amazon 17241456, ep.. date Aug-26 Amazon 17241457, ep.. date Aug-26 Amazon 17241892, ep.. date Oct-26 Amazon 17241893, ep.. date Oct-26 Amazon",
"scrapedAt": "2026-05-14T17:41:53.691Z"
},
{
"_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. Nationwide, Canada, and Australia.",
"recall_number": "D-0680-2019",
"product_description": "Dr. King's SafeCare Rx Lonely Mind & Body High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955200024, NDC 57955-2001-2",
"product_quantity": "53 bottles",
"reason_for_recall": "Microbial contamination",
"recall_initiation_date": "20180720",
"center_classification_date": "20190308",
"termination_date": "20220119",
"report_date": "20190320",
"code_info": "Lots: 010518H Exp. 01/20; 040616N Exp. 04/19",
"scrapedAt": "2026-05-14T17:41:53.783Z"
},
{
"_dataset": "drug/enforcement",
"status": "Terminated",
"city": "Little Rock",
"state": "AR",
"country": "United States",
"classification": "Class II",
"openfda": {},
"product_type": "Drugs",
"event_id": "77780",
"recalling_firm": "Cantrell Drug Company",
"address_1": "7321 Cantrell Rd",
"address_2": "N/A",
"postal_code": "72207-4144",
"voluntary_mandated": "Voluntary: Firm initiated",
"initial_firm_notification": "Letter",
"distribution_pattern": "Nationwide within the US",
"recall_number": "D-1074-2017",
"product_description": "Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-171-12",
"product_quantity": "46078 syringes",
"reason_for_recall": "Lack of Sterility Assurance.",
"recall_initiation_date": "20170714",
"center_classification_date": "20170809",
"termination_date": "20200916",
"report_date": "20170816",
"code_info": "Lot #: 9556, BUD: 7/26/2017; 9566, BUD: 7/30/2017; 9584, BUD; 8/1/2017; 9613, BUD: 8/6/2017; 9656, BUD: 8/14/2017; 9798, BUD: 9/11/2017; 9812, BUD: 8/31/2017; 9819, BUD: 9/16/2017; 9836, BUD: 9/17/2017; 9944, BUD: 10/3/2017; 10158, 10493, 10565, BUD: 10/30/2017",
"scrapedAt": "2026-05-14T17:41:53.806Z"
},
{
"_dataset": "drug/enforcement",
"country": "United States",
"city": "Lynwood",
"address_1": "11865 Alameda St",
"reason_for_recall": "Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.",
"address_2": "",
"product_quantity": "108,792 bottles",
"code_info": "Lot #: 73762, 80030, 82053, 83032, 73768, 76414, 78222, 78441, 140423, 140494, 142396,145460,145959, 73831, 73832, 78440, 79819, 82606, 80969, 140530, 142413, 145461, 74163; Exp 06/14 Lot #:148820, 149396, 149995, 150208, 150422, 150599, 151023, 151071,151337, 148931,151072. ; Exp 08/15",
"center_classification_date": "20140429",
"distribution_pattern": "Nationwide",
"state": "CA",
"product_description": "Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP, 10 mg (Cough Suppressant) , Guaifenesin, USP, 200 mg (Expectorant), 4, 8 fl oz bottles , OTC only, labeled as A) CareOne 8 fl oz bottle, Distributed by American Sales Company, Lancaster, NY 14086, UPC 341520339677, B) Our Family 4 fl oz bottle, Distributed by Nash Finch Company, NFC Brands, MPLS, MN 55435, UPC 070253579523, C) Premier Value 4, 8 fl oz bottle, Distributed by Chain Drug Consortium, LLC., Boca Raton, FL 33431, 4 fl oz UPC 840986024719; 8 fl oz UPC 840986024726, NDC 68016-177-XX, D) Rexall 4 fl oz bottle, Packaged for Dolencorp, LLC, Goodlettsville, TN 37072, UPC 715256714044, E) Safeway 4 fl oz, Distributed by Safeway INC, Pleasanton, CA 94566-0009, UPC 321130763581; F) Select Brand 4, 8 fl oz, Distributed by Select Brand Distributers, Pine Bluff, AR 71603, 4 fl oz UPC 015127024303; 8 fl oz UPC 015127024310.",
"report_date": "20140507",
"classification": "Class III",
"openfda": {},
"recalling_firm": "Aaron Industries Inc",
"recall_number": "D-1286-2014",
"initial_firm_notification": "Telephone",
"product_type": "Drugs",
"event_id": "68003",
"termination_date": "20150213",
"more_code_info": "",
"recall_initiation_date": "20140411",
"postal_code": "90262-4022",
"voluntary_mandated": "Voluntary: Firm initiated",
"status": "Terminated",
"scrapedAt": "2026-05-14T17:41:53.828Z"
},
{
"_dataset": "drug/enforcement",
"status": "Terminated",
"city": "San Francisco",
"state": "CA",
"country": "United States",
"classification": "Class II",
"openfda": {},
"product_type": "Drugs",
"event_id": "73662",
"recalling_firm": "Reliable Rexall-A Compounding Pharmacy",
"address_1": "801 Irving St",
"address_2": "N/A",
"postal_code": "94122-2310",
"voluntary_mandated": "Voluntary: Firm initiated",
"initial_firm_notification": "Press Release",
"distribution_pattern": "U.S. Including: CA, HI, NM",
"recall_number": "D-1135-2016",
"product_description": "All potassium bromide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",
"product_quantity": "N/A",
"reason_for_recall": "Lack of Processing Controls",
"recall_initiation_date": "20160325",
"center_classification_date": "20160706",
"termination_date": "20170410",
"report_date": "20160713",
"code_info": "All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",
"scrapedAt": "2026-05-14T17:41:53.850Z"
}
] |