FDA-Drug2016-11-30Class II

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

West-Ward Pharmaceuticals Corp.
Hazard

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

Sold states
Nationwide
Affected count
N/A
Manufactured in
401 Industrial Way West, N/A, Eatontown, NJ, United States
Products
Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01

Official notice

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

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