Carvedilol tablets recalled nationwide due to nitrosamine impurity
Glenmark Pharmaceuticals is recalling Carvedilol 3.125 mg tablets due to nitrosamine impurity above acceptable levels. Approximately 44,328 bottles were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for nitrosamine impurity above acceptable intake levels with no reported illnesses or injuries. This qualifies as a risk-of-harm product without reported injury, meeting the criterion for Score 3 (High).
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol tablets, USP, 3.125 mg. Approximately 44,328 bottles were distributed nationwide in 500-count bottles (NDC 68462-162-05) and 100-count bottles (NDC 68462-162-01).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Testing identified the presence of N-Nitroso Carvedilol I Impurity, a nitrosamine, at levels exceeding the current Acceptable Intake Level.
The affected lots are: 19242274, 19242275, and 19242272, with expiration dates of May 31, 2020 and May 31, 2026.
Consumers with affected bottles should contact their healthcare provider or pharmacy. The product was manufactured by Glenmark Pharmaceuticals Ltd in Goa, India, and manufactured for Glenmark Pharmaceuticals Inc. in Mahwah, New Jersey.
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Hazard
- nitrosamine
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot#: a)19242274
- 19242275
- 19242272
- Exp: 5/31/20
- b) 19242272
- Exp: 5/31/2026
UPCs (4)
- 0368462162019
- 0368462163016
- 0368462164013
- 0368462165010
Distribution
Distributed nationwide across the United States.
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