drugs Class II Updated 2014-05-07

Caraco Pharmaceutical Laboratories, Ltd. recalls Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg,

Recalled Product

Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5); and b) 90-count bottles (NDC 41616-760-81, UPC 3 41616 76081 1), Rx only, 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: a) JKL4344A, Exp 07/14; JKL5460A, Exp 10/14; JKL5458A, Exp 11/14; b) JKL4344B, Exp 07/14; JKL5460B, Exp 10/14; JKL5458B, Exp 11/14.
View official government recall

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