Class II
Terminated
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.
This recall has been terminated (originally issued November 8, 2017).
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- October 25, 2017
- Posted
- November 8, 2017
- Recall Number
- D-0069-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 140,993 bottles
- Firm Location
- North Wales, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Distribution
Nationwide in the USA and Puerto Rico.
Lot / Code Info
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.
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