Drug product
Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05) and b) 1000-count tablets per bottle (NDC 0143-1176-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
D-150-2013
Product summary
- Event
- Event 64103
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,585 bottles
- Official record key
drug-enforcement:D-150-2013
Official wording
Reason: Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.
Code information: Lot #: 69364A, 69365A, and 69365B, Exp 10/15
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance