FDA recall D-824-2013

West-Ward Pharmaceutical Corp. · Class II · drug

Product

West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724

Reason for recall

Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-05-16
Report date: 2013-07-31
Termination date: 2014-06-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Eatontown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-824-2013