Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured…
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Read the official notice →- Date
- 2025-02-12
- Country
- United States
- Brand
- Glenmark Pharmaceuticals
- Product
- Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark…
- Classification
- Class II
- Units
- Nationwide in the U.S
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Glenmark Pharmaceuticals recalls
- 2025-04-16
US- 2025-04-09
- US
Glenmark Pharmaceuticals Inc., USA recalls chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals…
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
- 2025-02-26
- US
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,…
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- 2025-01-01
- US
Glenmark Pharmaceuticals Inc., USA recalls chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc.,…
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
- 2024-12-11
- US
Glenmark Pharmaceuticals Inc., USA recalls Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for:…
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
- 2024-10-09
- US
Glenmark Pharmaceuticals Inc., USA recalls Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered…
Defective Delivery System: The dip tube is clogged causing the spray not to work.
Other drugs & medical recalls in the United States
- 2025-02-12
- US
SKY PACKAGING recalls HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India,…
Failed Impurities/Degradation Specifications
- US
Teva Pharmaceuticals USA, Inc recalls Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC…
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
- US
RemedyRepack Inc. recalls Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged…
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
- US
FDC Limited recalls Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad,…
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.
- 2025-02-05
- US
Murata Vios, Inc. recalls muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central…
FDA · DeviceMurata Vios, Inc.Worldwide - US Nationwide distribution in the states of NY, TX, OH, MD and the…Official notice → - US
LivaNova USA, Inc. recalls Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description:…
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
FDA · DeviceLivaNova USA, Inc.Worldwide - US Nationwide distribution including in the states of AK, AZ, CA,…Official notice →