FDA Drug · D-1111-2017

Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10

Class I · Terminated

Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets

Affected lots / codes — check yours against thisLot # 70952A; Exp. 11/17

Recalling firm: C. O. Truxton, Bellmawr, NJ
Classification: Class I (most serious — risk of serious harm)
Status: Terminated
Quantity: unknown
Distribution: Nationwide
Recall initiated: April 20, 2017
Classified: August 22, 2017
Terminated: September 11, 2018
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1111-2017%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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