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U.S. Department of Health and Human Services

Enforcement Report - Week of May 7, 2014

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Product Detail

Product Description GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05
Recall Number D-1293-2014
Classification Class II
Code Info TE36018, Exp. 06/15
Product Distributed Qty 2532 bottles
Reason For Recall This recall was initiated because laboratory testing was not followed in accordance with GMP requirements.

Event Detail

Event Id 67811
Product Type Drugs
Status Ongoing
Recalling Firm Teva Pharmaceuticals USA
City Horsham
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-24
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide