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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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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
Distribution Pattern GA

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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, Lot 69968B 03/14 Class II 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. 118 bottles D-839-2013