FDA recall D-883-2013

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-07-30

Report date

2013-08-21

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-883-2013