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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 METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-2932-01
Recall Number D1292-2014
Classification Class II
Code Info TE36053A,TE36063A, Exp. 06/16
Product Distributed Qty 22820 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