FDA-Drug2013-08-21Class II

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.

West-Ward Pharmaceutical Corp.
Hazard

Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets

Sold states
Nationwide
Affected count
1000 count bottles/61,370 and 5000 count bottles/321
Manufactured in
465 Industrial Way W, Eatontown, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-883-2013

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