Recalls / Class II
Class IID-824-2013
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
- Affected lot / code info
- Lot # 69098A, 69098B, 69100A; Exp 8/15
Why it was recalled
Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on 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
- 14,503 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-05-16
- FDA classified
- 2013-07-25
- Posted by FDA
- 2013-07-31
- Terminated
- 2014-06-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-824-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.