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.
FDA recall notice · announced August 21, 2013 · West-ward Pharmaceutical
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Reason for recall
Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets
Notes
Distribution: Nationwide
Lot/code information: 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.
Quantity: 1000 count bottles/61,370 and 5000 count bottles/321
Status: Terminated
Products in this recall event:
- 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., (D-883-2013)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.