Drug product
Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets per bottle (NDC 0143-1140-10; b) 5000-count tablets per bottle (NDC 143-1140-51); Rx only, Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724
D-170-2013
Product summary
- Event
- Event 64107
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,511 bottles
- Official record key
drug-enforcement:D-170-2013
Official wording
Reason: Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
Code information: Lot #: 69099A, 69099B, Exp 08/15
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance