Carvedilol Tablets 12.5 mg Recalled for Impurity Above Limit
Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 12.5 mg due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit, resulting from current Good Manufacturing Practice (CGMP) deviations.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as Class II. The presence of an impurity above the recommended acceptable intake limit in a prescription cardiovascular medication, combined with CGMP deviations, represents a significant quality and safety issue that meets the Severe severity threshold.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 12.5 mg in 500-count bottles distributed nationwide. The recall is due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit and CGMP deviations.
The affected product is Carvedilol Tablets USP 12.5 mg, NDC 68462-164-05, with the following lot numbers and expiration dates: Lots 19231899, 19231922, 19231927, 19231967, 19231979 (Exp Apr-25); Lots 19232226, 19232234, 19232265, 19232271 (Exp May-25); Lots 19232758, 19232759, 19232762, 19232788 (Exp Jun-25). A total of 84,048 bottles have been distributed in the U.S.
Patients currently taking this medication should consult their healthcare provider before taking any action. Healthcare providers and patients should contact Glenmark Pharmaceuticals Inc., USA for further information regarding this recall.
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Affected units
- 84,048
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 (17)
- Lot
- Exp: Lots 19231899
- 19231922
- 19231927
- 19231967
- 19231979
- Exp Apr-25
- Lots 19232226
- 19232234
- 19232265
- 1923227
- 1 Exp May-25
- Lots 19232758
- 19232759
- 19232762
- 19232788
- Exp Jun-25
UPCs (4)
- 0368462162019
- 0368462163016
- 0368462164013
- 0368462165010
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Glenmark Pharmaceuticals Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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