FDA Drug Moderate Class II Terminated

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.

Reported: August 21, 2013 Initiated: July 30, 2013 #D-883-2013

Product Description

Reason for Recall

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

Details

Recalling Firm: West-Ward Pharmaceutical Corp.
Units Affected: 1000 count bottles/61,370 and 5000 count bottles/321
Distribution: Nationwide
Location: Eatontown, NJ

Frequently Asked Questions

What product was recalled? ▼

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.. Recalled by West-Ward Pharmaceutical Corp.. Units affected: 1000 count bottles/61,370 and 5000 count bottles/321.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on August 21, 2013. Severity: Moderate. Recall number: D-883-2013.