Recalls / Class II
Class IID-0069-2018
Product
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.
- Affected 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.
Why it was recalled
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 140,993 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2017-10-25
- FDA classified
- 2017-11-02
- Posted by FDA
- 2017-11-08
- Terminated
- 2018-05-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0069-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.