FDAClass IINovember 30, 2016

Phenobarbital Tablets recall: Failed Dissolution

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

Why was Phenobarbital Tablets recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 71294A, Exp. 5/2017

Product
Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01
Recalling firm
West-Ward Pharmaceuticals Corp.
Quantity
N/A
Distribution
Nationwide
Recall date
November 30, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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