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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960
Recall Number D-1295-2014
Classification Class II
Code Info TE38139, Exp. 08/16, TE39022, Exp. 09/16,
Product Distributed Qty 5812 bottles
Reason For Recall CGMP Deviations; 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