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U.S. Department of Health and Human Services

Enforcement Report - Week of July 9, 2014

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Product Detail

Product Description Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. 30-Count Bottle NDC: 41616-758-83, 90-Count Bottle: NDC 41616-758-81.
Recall Number D-1415-2014
Classification Class II
Code Info 30 Count Bottle: Lot #: JKL5054A, Expiry: 08/2014; Lot #: JKM2305A, Expiry: 03/2015. 90 Count Bottle: Lot #: JKL5054B, Expiry: 08/2014; Lot #: JKM2305B, Expiry: 03/2015.
Product Distributed Qty 26,530 30-Count Bottles; 14,597 90-Count Bottles
Reason For Recall Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.

Event Detail

Event Id 68637
Product Type Drugs
Status Ongoing
Recalling Firm Caraco Pharmaceutical Laboratories, Ltd.
City Detroit
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-06-12
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide including Puerto Rico