Recalls / Class II
Class IID-883-2013
Product
Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724.
- Affected lot / code info
- 1000's: Catalog #1140-10; Lot #/Expiry Dates: 67328A; 67329A; 67330B; 67330C/Dec 2013; 68064B; 68065A/Jan 2014; 68666B; 68667A/May 2015; 69721A/Dec 2015 and 69722A/Jan 2016. 5000's: Catalog #1140-51; Lot #/Expiry Dates: 68064A/Jan 2015 and 68666A/May 2015.
Why it was recalled
Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets
Recalling firm
- Firm
- West-Ward Pharmaceutical Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 465 Industrial Way W, Eatontown, New Jersey 07724-2209
Distribution
- Quantity
- 1000 count bottles/61,370 and 5000 count bottles/321
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-07-30
- FDA classified
- 2013-08-12
- Posted by FDA
- 2013-08-21
- Terminated
- 2014-06-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-883-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.