Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2,…
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Read the official notice →- Date
- 2025-08-20
- Country
- United States
- Brand
- Glenmark Pharmaceuticals
- Product
- Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2,…
- Classification
- Class II
- Units
- Nationwide within the USA
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
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Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
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Failed Impurities/Degradation Specifications
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Glenmark Pharmaceuticals Inc., USA recalls Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited…
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Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez,…
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
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Other drugs & medical recalls in the United States
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Philips Respironics, Inc. recalls DreamStation Auto BiPAP. Non-Continuous Ventilator.
Devices may possess a programming error resulting in an incorrect device configuration.
FDA · DevicePhilips Respironics, Inc.Worldwide - US Nationwide in the states of AL, CA, CO, FL, GA, IN, LA, MD, NE,…Official notice → - US
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B BRAUN MEDICAL INC recalls 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun…
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Merck & Co. Inc recalls Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp…
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