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U.S. Department of Health and Human Services

Enforcement Report - Week of July 9, 2014

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Product Detail

Product Description Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-01, e) 1000-count bottles, NDC 61748-013-10, Mfd. for: VersaPharm Incorporated, Marietta, GA 30062; Mfd. by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
Recall Number D-1414-2014
Classification Class II
Code Info Lot #: a) 67839A, 67839D, Exp 05/14; 67936A, Exp 02/15; b) 67839B, 67840C, Exp 05/14; 67936B, Exp 02/15; c) 67840A, Exp 05/14; d) 67840B, Exp 05/14; e) 67839C, Exp 05/14
Product Distributed Qty a) 17,347 bottles, b) 3,015 bottles, c) 1,334 bottles, d) 5,651 bottles, e) 210 bottles
Reason For Recall Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.

Event Detail

Event Id 68502
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 2014-05-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide