Ascend Laboratories LLC recalls Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., M…
- Recall date
- February 22, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1066-2019
- FDA classification
- Class II
- Brand / firm
- Ascend Laboratories LLC
- Sold / distributed
- Nationwide in the USA and Puerto Rico.
Why it was recalled
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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