Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

2,152 results found for contamination Page 19 of 87
Perrigo Company PLC
Class II Terminated
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-82; NDC CVS Health: 59779-540-82; NDC HEB: 37808-507-82; NDC Signature Ca...
Reason: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
D-1028-2020 March 25, 2020 Allegan, MI
Perrigo Company PLC
Class II Terminated
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-293-65; NDC Equaline 41163-931-65; NDC Family Wellness: 55319-876-65; NDC Good S...
Reason: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
D-1012-2020 March 25, 2020 Allegan, MI
Perrigo Company PLC
Class II Terminated
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75; NDC Up & Up: 11673-950-75
Reason: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
D-1025-2020 March 25, 2020 Allegan, MI
Perrigo Company PLC
Class II Terminated
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per bottle. [NDC: Brand] NDC Basic Care: 0113-7876-27; NDC CVS Health: 69842-293-27; NDC Leader: 70000-0375-2; NDC Up & Up: 11...
Reason: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
D-1014-2020 March 25, 2020 Allegan, MI
Perrigo Company PLC
Class II Terminated
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per bottle. [Brand, NDC] NDC DG Health: 55910-852-71; NDC Good Neighbor Pharmacy: 46122-224-71; NDC Good Sense: 0113-0852-71; ...
Reason: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
D-1021-2020 March 25, 2020 Allegan, MI
Perrigo Company PLC
Class II Terminated
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-608-75; NDC Up & Up: 11673-023-75
Reason: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
D-1024-2020 March 25, 2020 Allegan, MI
Perrigo Company PLC
Class II Terminated
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-09; NDC CVS Health: 59779-950-09; NDC Equate: 49035-800-09; NDC G...
Reason: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
D-1023-2020 March 25, 2020 Allegan, MI
Perrigo Company PLC
Class II Terminated
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58
Reason: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
D-1020-2020 March 25, 2020 Allegan, MI
Perrigo Company PLC
Class II Terminated
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2; NDC Major: 0904-6715-52; NDC Meijer: 41250-252-72; NDC Sunmark: 49348-...
Reason: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
D-1013-2020 March 25, 2020 Allegan, MI
Perrigo Company PLC
Class II Terminated
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per bottle. [NDC: Brand] NDC CVS Health.: 69842-293-06
Reason: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
D-1016-2020 March 25, 2020 Allegan, MI
Taro Pharmaceuticals U.S.A., Inc.
Class I Terminated
Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, ND...
Reason: Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
D-0833-2020 February 19, 2020 Hawthorne, NY
Efficient Laboratories, Inc.
Class II Terminated
Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166.UPC 0 00856 33106 8
Reason: Microbial Contamination of Non-Sterile Products
D-0845-2020 February 19, 2020 Miami, FL
Efficient Laboratories, Inc.
Class II Terminated
Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 30106 1
Reason: Microbial Contamination of Non-Sterile Products
D-0846-2020 February 19, 2020 Miami, FL
Efficient Laboratories, Inc.
Class II Terminated
New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 00309 5
Reason: Microbial Contamination of Non-Sterile Products
D-0847-2020 February 19, 2020 Miami, FL
Sigan Industries Inc.
Class III Terminated
Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET WT 14 OZ (396 g), NDC 65365-266-01, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.
Reason: Microbial contamination of non-sterile product.
D-0782-2020 January 22, 2020 Brampton
Lannett Company, Inc.
Class I Terminated
Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80
Reason: Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
D-0630-2020 December 25, 2019 Philadelphia, PA
OraLabs, Incorporated
Class II Terminated
Petroleum jelly (White Petrolatum) USP 100%, packaged in a) 1 oz tube (UPC 1182298884), b) 2.5 oz tube (UPC 1182298541), Distributed by Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011
Reason: Cross contamination with other products: undeclared contaminants of phenol and camphor in petroleum jelly tubes.
D-0624-2020 December 18, 2019 Parker, CO
Fagron, Inc
Class II Terminated
LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate - 180 mg, Tetracaine Hydrochloride - 500 mg, Sodium ...
Reason: Microbial contamination of non-sterile product.
D-0533-2020 December 11, 2019 Saint Paul, MN
Apotex Inc.
Class II Completed
Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06 Distributed By: Wal-Mart Stores, Inc. Bentonville, AR 72716
Reason: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
D-0318-2020 November 20, 2019 North York, N/A
Apotex Inc.
Class II Completed
Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack NDC: 49035-100-07; b) Single Pack NDC: 49035-100...
Reason: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
D-0316-2020 November 20, 2019 North York, N/A
Apotex Inc.
Class II Completed
Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 a) 200 Tablets NDC 0363-1030-07; b) 24 Tablets NDC ...
Reason: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
D-0314-2020 November 20, 2019 North York, N/A
Apotex Inc.
Class II Completed
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-...
Reason: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
D-0319-2020 November 20, 2019 North York, N/A
Apotex Inc.
Class II Completed
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer 24 Tablets Sugar Free NDC 11822-6107-4 Distributed By: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011
Reason: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
D-0317-2020 November 20, 2019 North York, N/A
Apotex Inc.
Class II Completed
Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30 Tablets NDC 0363-1029-03 Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015
Reason: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
D-0315-2020 November 20, 2019 North York, N/A
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
Class II Terminated
PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Exten...
Reason: GMP Deviations: potential glass contamination
D-0147-2020 October 30, 2019 West Columbia, SC