Teva Pharmaceuticals USA recalls Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count
Recalled November 8, 2017 · FDA recall D-0069-2018 · Teva Pharmaceuticals USA
Hazard
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results. · FDA Class II
Units
140,993 bottles
Sold at
Nationwide in the USA and Puerto Rico.
Description
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Product
Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA.
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →