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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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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
Distribution Pattern GA

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 67079A; 67079B; 67079C Class II Failed Dissolution Specifications; 36 month stability timepoint 77531 bottles D-174-2013