FDA Drug Recalls

December 19, 2024 · DrugView details →

ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25

Hikma Injectables USA Inc

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

December 19, 2024 · DrugView details →

phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25

Hikma Injectables USA Inc

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

December 18, 2024 · DrugView details →

Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03

Granules Pharmaceuticals Inc.

Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.

December 18, 2024 · DrugView details →

medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acetate Injectable Suspension, USP, 150 mg per mL, Distributed by: Eugia US LLC, NJ, Manufactured by: Eugia Pharma Specialties Limited, India

Eugia US LLC

CGMP Deviations

December 17, 2024 · DrugView details →

glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11

Amerisource Health Services LLC

Failed Dissolution Specifications:

December 16, 2024 · DrugView details →

Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05

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

December 13, 2024 · DrugView details →

Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-21

Amerisource Health Services LLC

Presence of Foreign Tablets/Capsules

December 12, 2024 · DrugView details →

Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60

Ascend Laboratories, LLC

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

December 12, 2024 · DrugView details →

Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60

Ascend Laboratories, LLC

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

December 11, 2024 · DrugView details →

chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

December 11, 2024 · DrugView details →

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack

VIONA PHARMACEUTICALS INC

Crystallization

LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-006-01

Regenerative Processing Plant, LLC

Lack of Sterility Assurance

PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-003-01

Regenerative Processing Plant, LLC

Lack of Sterility Assurance

Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack

VIONA PHARMACEUTICALS INC

Crystallization

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

Breckenridge Pharmaceutical, Inc

CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05

Amerisource Health Services LLC

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.

Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04

Amerisource Health Services LLC

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.

Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04

Amerisource Health Services LLC

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.

Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. NDC: 59651-137-30

Aurobindo Pharma USA Inc

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.