Recalls / Class II
Class IID-170-2013
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
- Affected lot / code info
- Lot #: 69099A, 69099B, Exp 08/15
Why it was recalled
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
Recalling firm
- Firm
- West-ward Pharmaceutical Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 465 Industrial Way W, N/A, Eatontown, New Jersey 07724-2209
Distribution
- Quantity
- 6,511 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-01-07
- FDA classified
- 2013-02-27
- Posted by FDA
- 2013-03-06
- Terminated
- 2015-01-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-170-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.