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FDA Recalls

Showing 4,141–4,150 of 18,043 recalls

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🍔 Food 💊 Drugs 🏥 Medical Devices

Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-998-67 Class II

Reason: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

McKesson Corporation dba McKesson Drug Company 20220421 Ongoing

Distributed: Nationwide in the United States including Guam and the Northern Mariana Islands.

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, NDC 50383-775-04 Class III

Reason: Failed viscosity specification - product was below specificcation

Akorn, Inc. 20220415 Terminated

Distributed: Nationwide USA and Puerto Rico

alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1. Class II

Reason: Failed Dissolution Specifications: low out-of-specification dissolution test results observed.

Viatris Inc 20220428 Terminated

Distributed: Product was distributed nationwide in the USA

Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA Class II

Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Lupin Pharmaceuticals Inc. 20220331 Terminated

Distributed: Product was distributed nationwide

Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 68180-217-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA Class II

Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Lupin Pharmaceuticals Inc. 20220331 Terminated

Distributed: Product was distributed nationwide

Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA. Class II

Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Lupin Pharmaceuticals Inc. 20220331 Terminated

Distributed: Product was distributed nationwide

Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA. Class II

Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Lupin Pharmaceuticals Inc. 20220331 Terminated

Distributed: Product was distributed nationwide

Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA. Class II

Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Lupin Pharmaceuticals Inc. 20220331 Terminated

Distributed: Product was distributed nationwide

Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA. Class II

Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Lupin Pharmaceuticals Inc. 20220331 Terminated

Distributed: Product was distributed nationwide

Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC # 33342-051-10) c) 1000-count bottles (NDC # 33342-051-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Class II

Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Macleods Pharma Usa Inc 20220415 Terminated

Distributed: Product was distributed nationwide.

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