Drug product
West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724
D-824-2013
Product summary
- Event
- Event 65445
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,503 bottles
- Official record key
drug-enforcement:D-824-2013
Official wording
Reason: Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.
Code information: Lot # 69098A, 69098B, 69100A; Exp 8/15
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance