Drug product
Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, List No. 152, NDC 10135-152-01, UPC 3 10135 15201 8.
D-1064-2013
Product summary
- Event
- Event 65967
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28,387 bottles
- Official record key
drug-enforcement:D-1064-2013
Official wording
Reason: CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing practices as noted by a recent inspection of the manufacturing firm.
Code information: Lot #: 3213, Exp 12/13
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations