FDA-Drug2017-11-08Class II
Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA.
Teva Pharmaceuticals USA
Hazard
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Sold states
Nationwide in the USA and Puerto Rico.
Affected count
140,993 bottles
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0069-2018Don't want to check this manually?
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