Drug recall D-1045-2017

Class II Terminated reported Nov 30, 2016

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

Lots and codes

Lot #: 71294A, Exp. 5/2017

Recall details

Recalling firm
West-Ward Pharmaceuticals Corp., Eatontown, NJ
Quantity
N/A
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
October 3, 2016
Terminated
December 26, 2017

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