FDA recall D-1045-2017

West-Ward Pharmaceuticals Corp. · Class II · drug

Product

Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01

Reason for recall

Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2016-10-03
Report date
2016-11-30
Termination date
2017-12-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Eatontown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1045-2017