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.
Reason for recall: Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Recall initiated: 20171025
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated