FDA-Drug2019-03-13Class II
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.
Ascend Laboratories LLC
Hazard
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
Sold states
Nationwide in the USA and Puerto Rico.
Affected count
3,072 bottles
Manufactured in
339 Jefferson Rd Ste 101, N/A, Parsippany, NJ, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1066-2019Don't want to check this manually?
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