FDAFDA · Food and drugs·Recall number D-0069-2018
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.
Published November 8, 2017 · Recall initiated: October 25, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Nationwide in the USA and Puerto Rico.
- Lot
- Lot Numbers: a) 1089376A, 1089382A, 1095210M, 1117768M, 1117769A, Exp. 11/17; 1128452A, 1128453A, 1137658A, 1154207A, 1156087A, Exp. 03/18; b) 1089379A, 1091533M, 1125206A, Exp. 11/17; 1128456A, 1147665A, 1154208A, 1156088A, Exp. 03/18.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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