Caraco Pharmaceutical Laboratories, Ltd. recalls Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41
Recalled May 7, 2014 · FDA recall D-1284-2014 · Caraco Pharmaceutical Laboratories
Hazard
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications. · FDA Class II
Units
91,777 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, 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.
Manufacturer(s)
Caraco Pharmaceutical Laboratories, Ltd.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →