Drug product
Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3.
D-137-2013
Product summary
- Event
- Event 64154
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,580 bottles
- Official record key
drug-enforcement:D-137-2013
Official wording
Reason: Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
Code information: Lot #: ZCMH12031, ZCMH12032, ZCMH12033, ZCMH12034, Exp 02/14
Distribution pattern: Nationwide.
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.