Caraco Pharmaceutical Laboratories, Ltd. recalls Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distribu
Recalled July 9, 2014 · FDA recall D-1415-2014 · Caraco Pharmaceutical Laboratories
Hazard
Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications. · FDA Class II
Units
26,530 30-Count Bottles; 14,597 90-Count Bottles
Sold at
Nationwide including Puerto Rico
Description
Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
Product
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.
Manufacturer(s)
Caraco Pharmaceutical Laboratories, Ltd.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →