Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-450-05.

Recall Number: D-1066-2019

Firm: Ascend Laboratories LLC

Classification: Class II

Status: Terminated

Report Date: 20190313

Initiation Date: 20190222

Termination Date: 20200318

Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.

Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-450-05.