Caraco Pharmaceutical Laboratories, Ltd. recalls Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 416
Recalled May 7, 2014 · FDA recall D-1283-2014 · Caraco Pharmaceutical Laboratories
Hazard
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications. · FDA Class II
Units
160,105 bottles
Sold at
Nationwide and Puerto Rico
Description
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Product
Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2); and b) 90-count bottles (NDC 41616-758-81, UPC 3 41616 75881 8), 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.
Manufacturer(s)
Caraco Pharmaceutical Laboratories, Ltd.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →