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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 861–880 of 1,000 recalls

Class IICompleted

fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01

Fagron Compounding Services

Lack of Assurance of Sterility

January 31, 2025 · DrugView details →

Class IIOngoing

Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Failed Dissolution Specifications.

January 30, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IITerminated

Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.

RemedyRepack Inc.

CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.

January 24, 2025 · DrugView details →

Class IIOngoing

HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-328-10

SKY PACKAGING

Failed Impurities/Degradation Specifications

January 24, 2025 · DrugView details →

Class IIOngoing

HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-327-10

SKY PACKAGING

Failed Impurities/Degradation Specifications

January 24, 2025 · DrugView details →

Class IIOngoing

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.

FDC Limited

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

January 23, 2025 · DrugView details →

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