Recall: D-1066-2019

Class II - Potentially Harmful

Class IIClassification

2019-02-22Initiated

TerminatedStatus

Ascend Laboratories LLCFirm

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.

Reason

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

Distribution

Nationwide in the USA and Puerto Rico.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.