Class II Terminated

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.

Company: Caraco Pharmaceutical Laboratories, Ltd.
Recall Initiated: June 12, 2014
Posted: July 9, 2014
Recall Number: D-1415-2014
Voluntary / Mandated: Voluntary: Firm initiated
Quantity: 26,530 30-Count Bottles; 14,597 90-Count Bottles
Firm Location: Detroit, MI, United States

Reason for Recall

Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.

Distribution

Nationwide including Puerto Rico

Lot / 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.

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View all recalls by this company →

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