Lupin Pharmaceuticals Inc. recalls Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only,…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Read the official notice →- Date
- 2022-05-11
- Country
- United States
- Brand
- Lupin Pharmaceuticals
- Product
- Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only,…
- Classification
- Class II
- Units
- Product was distributed nationwide
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Lupin Pharmaceuticals recalls
- 2022-08-24
USLupin Pharmaceuticals Inc. recalls Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202…
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
- 2022-06-22
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Lupin Pharmaceuticals Inc. recalls Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD…
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
FDA · DrugLupin Pharmaceuticals Inc.Product was distributed to 10 wholesalers/distributors and one mail order…Official notice → - 2022-05-25
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Lupin Pharmaceuticals Inc. recalls GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
Failed Stability Specification
FDA · DrugLupin Pharmaceuticals Inc.Product was distributed nationwide, including Puerto Rico.Official notice → - 2022-01-12
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Lupin Pharmaceuticals Inc. recalls Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore,…
Out-of-specification impurity test result observed at 18-month long term stability time point.
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Lupin Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC…
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
- 2021-12-08
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Other drugs & medical recalls in the United States
- 2022-05-11
- US
McKesson Corporation dba McKesson Drug Company recalls Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent…
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
FDA · DrugMcKesson Corporation dba McKesson Drug CompanyNationwide in the United States including Guam and the Northern Mariana Islands.Official notice → - US
Akorn, Inc. recalls Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc.…
Failed viscosity specification - product was below specificcation
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Viatris Inc recalls alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1.
Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
- US
Macleods Pharma Usa Inc recalls Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
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SCA Pharmaceuticals recalls Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44
CGMP Deviations
FDA · DrugSCA PharmaceuticalsProduct was distributed nationwide within the United StatesOfficial notice → - 2022-05-04
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Freudenberg Medical, Llc recalls Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
FDA · DeviceFreudenberg Medical, LlcUS distribution: GA, OH Foreign distribution: NetherlandsOfficial notice →