Drug product
Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05
D-0063-2023
Product summary
- Firm
- Viatris Inc
- Event
- Event 91038
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,794 bottles
- Official record key
drug-enforcement:D-0063-2023
Official wording
Reason: Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
Code information: Lot #: 3150116, Exp 2/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.