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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Product Detail

Product Description a)60 tablets NDC 61748-014-06, b)90 tablets, NDC 61748-014-09, c)100 tablets, NDC 61748-014-01, d)1000 tablets, NDC 61748-014-10, e) blister pack (10s) 61748-014-11
Recall Number D-189-2013
Classification Class II
Code Info 69877A; 68977B; 68978B; 6978C; 68979A - exp JUL 2015 68977C; 68978A exp JUL 2013
Product Distributed Qty 18,825 bottles
Reason For Recall Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.

Event Detail

Event Id 64105
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 2012-11-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern GA