Ascend Laboratories LLC recalls Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mu
Recalled March 13, 2019 · FDA recall D-1066-2019 · Ascend Laboratories
Hazard
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing. · FDA Class II
Units
3,072 bottles
Sold at
Nationwide in the USA and Puerto Rico.
Description
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
Product
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.
Manufacturer(s)
Ascend Laboratories LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →