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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

Product Description Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC 61748-013-01, Mfd for: VersaPharm Incorporated Marietta, GA 30065-1505, Mfd by: West - Ward Pharmaceutical Corp.., Eatontown, NJ 07724
Recall Number D-174-2013
Classification Class II
Code Info 67079A; 67079B; 67079C
Product Distributed Qty 77531 bottles
Reason For Recall Failed Dissolution Specifications; 36 month stability timepoint

Event Detail

Event Id 64106
Product Type Drugs
Status Ongoing
Recalling Firm West-ward Pharmaceutical Corp.
City Eatontown
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern GA