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Drugs Recalls

Prescription and over-the-counter medications

17,685 Total Recalls

Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-575-21; NDC Unit Dose: 60687-575-11

Amerisource Health Services

Class I - Dangerous

Failed Impurities/Degradation Specification.

Jan 11, 2024 Prescription Drugs Nationwide View Details →

Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01

Lupin Pharmaceuticals

Class I - Dangerous

Failed Impurities/Degradation Specifications

Jan 3, 2024 Prescription Drugs Nationwide View Details →

Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06

Lupin Pharmaceuticals

Class I - Dangerous

Subpotent Drug and Failed Impurities/Degradation Specifications

Jan 5, 2024 Prescription Drugs View Details →

OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000 4.

Den-Mat Holdings

Class I - Dangerous

CGMP Deviations: products may not conform to the labeled specifications.

Jan 16, 2024 Prescription Drugs Nationwide View Details →

Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-639-83.

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Jan 18, 2024 Prescription Drugs Nationwide View Details →

Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-308-88.

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Jan 18, 2024 Prescription Drugs Nationwide View Details →

Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL 68045, NDC 61703-332-18

PFIZER

Class I - Dangerous

Presence of particulate matter: glass

Dec 21, 2023 Prescription Drugs Nationwide View Details →

Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 63304-175-13.

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Jan 18, 2024 Prescription Drugs Nationwide View Details →

Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

Haleon US Holdings

Class I - Dangerous

Microbial Contamination of Non-Sterile Products

Dec 26, 2023 Other Drugs Nationwide View Details →

Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), India, NDC 47335-380-83.

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Jan 18, 2024 Prescription Drugs Nationwide View Details →

Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-579-83.

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Jan 18, 2024 Prescription Drugs Nationwide View Details →

Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-539-81.

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Jan 18, 2024 Prescription Drugs Nationwide View Details →

Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-613-81.

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Jan 18, 2024 Prescription Drugs Nationwide View Details →

Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-722-83.

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Jan 18, 2024 Prescription Drugs Nationwide View Details →

Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India. Distributed by:Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-752-16

Strides Pharma

Class I - Dangerous

Failed Dissolution Specifications

Dec 29, 2023 Prescription Drugs Nationwide View Details →

Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

Haleon US Holdings

Class I - Dangerous

Microbial Contamination of Non-Sterile Products

Dec 26, 2023 Other Drugs Nationwide View Details →

Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 47335-721-83.

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Jan 18, 2024 Prescription Drugs Nationwide View Details →

Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-307-88.

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Jan 18, 2024 Prescription Drugs Nationwide View Details →

Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11

Amerisource Health Services

Class I - Dangerous

Superpotent drug: Assay results were slightly above specification at the time zero point.

Dec 26, 2023 Prescription Drugs Nationwide View Details →

Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per bottle, NDC 51316-800-45; Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, Made in India, c) 150 Tablets per bottle, NDC 51660-998-55, Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India.

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Jan 18, 2024 Prescription Drugs Nationwide View Details →