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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Detail

Product Description VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown, NJ 07724 NDC 61748-014-06,
Recall Number D-839-2013
Classification Class II
Code Info Lot 69968B 03/14
Product Distributed Qty 118 bottles
Reason For Recall Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.

Event Detail

Event Id 65582
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 2013-06-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern GA
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