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FDAFebruary 22, 2019drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

ascend laboratoriesascend

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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