Lupin Pharmaceuticals Inc. recalls Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09)…
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Read the official notice →- Date
- 2021-11-10
- Country
- United States
- Brand
- Lupin Pharmaceuticals
- Product
- Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx…
- Classification
- Class II
- Units
- Product was distributed to major distributors who may have further distributed…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-05-11
USLupin 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
- 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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- 2021-11-03
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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.
- 2021-10-27
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Lupin Pharmaceuticals Inc. recalls Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202…
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Other drugs & medical recalls in the United States
- 2021-11-10
- US
Windstone Medical Packaging, Inc. recalls Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions…
Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. Potential for the plunger to draw back after air has been expelled and reintroduce air back into the syringe.
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MERCK SHARP & DOHME CORP recalls Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of…
Presence of Particulate Matter: Identified as Glass Particles
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Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals recalls Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c)…
Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
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Dr. Reddy's Laboratories, Inc. recalls Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories…
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in…
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Dr. Reddy's Laboratories, Inc. recalls Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-90)…
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
- 2021-11-03
- US
Elekta, Inc. recalls Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
FDA · DeviceElekta, Inc.Distribution throughout USA OUS distribution including:Algeria, Argentina,…Official notice →