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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 161–180 of 1,000 recalls

Class IITerminated

Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000345, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

Bestco LLC

CGMP Deviations: Potential Glass and Silicone particulates in product

January 19, 2024 · DrugView details →

Class IITerminated

Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000064, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

Bestco LLC

CGMP Deviations: Potential Glass and Silicone particulates in product

January 19, 2024 · DrugView details →

Class IITerminated

Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160 drops per bag, item number 20000463, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

Bestco LLC

CGMP Deviations: Potential Glass and Silicone particulates in product

January 19, 2024 · DrugView details →

Class IITerminated

Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials

OMEZA LLC

CGMP Deviations

January 19, 2024 · DrugView details →

Class IITerminated

Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS

OMEZA LLC

CGMP Deviations

January 19, 2024 · DrugView details →

Class IITerminated

Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops per bag, item number 20001187, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

Bestco LLC

CGMP Deviations: Potential Glass and Silicone particulates in product

January 19, 2024 · DrugView details →

Class IITerminated

Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 60219-1502-01

Amneal Pharmaceuticals of New York, LLC

Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.

January 15, 2024 · DrugView details →

Class IITerminated

Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30

Golden State Medical Supply Inc.

Failed Dissolution Specifications

January 12, 2024 · DrugView details →

Class IITerminated

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 LLC

Failed Impurities/Degradation Specification.

January 11, 2024 · DrugView details →

Class IITerminated

Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial, Rx Only, Distributed by BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511, Made in India, NDC 71839-104-01.

BE PHARMACEUTICALS AG

Lack of Sterility Assurance: Aseptic process simulation failure.

January 10, 2024 · DrugView details →

Class IITerminated

Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06

Lupin Pharmaceuticals Inc.

Subpotent Drug and Failed Impurities/Degradation Specifications

January 5, 2024 · DrugView details →

Class IITerminated

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 Inc.

Subpotent Drug and Failed Impurities/Degradation Specifications

January 5, 2024 · DrugView details →

Class IITerminated

Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pradesh - 173205, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-185-56

Glenmark Pharmaceuticals Inc., USA

Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol

January 4, 2024 · DrugView details →

Class IITerminated

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 Inc.

Failed Impurities/Degradation Specifications

January 3, 2024 · DrugView details →

Class IITerminated

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 Inc.

Failed Dissolution Specifications

December 29, 2023 · DrugView details →

Class IITerminated

Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10

Amneal Pharmaceuticals of New York, LLC

Failed dissolution specifications

December 26, 2023 · DrugView details →

Class IITerminated

Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202.

Lupin Pharmaceuticals Inc.

CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.

December 20, 2023 · DrugView details →

Class IITerminated

Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01

Dr. Reddy's Laboratories, Inc.

Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.

December 15, 2023 · DrugView details →

Class IITerminated

Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, 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 62756-589-88

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurities/Degradation Specifications

December 4, 2023 · DrugView details →

Class IITerminated

Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Lupin Limited, Nagpur-441 108, India, NDC# 70748-153-01

Lupin Pharmaceuticals Inc.

Failed Dissolution Specifications

November 22, 2023 · DrugView details →

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