Drug 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.
D-883-2013
Product summary
- Event
- Event 65844
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1000 count bottles/61,370 and 5000 count bottles/321
- Official record key
drug-enforcement:D-883-2013
Official wording
Reason: Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets
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.
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance