Reported Nov 8, 2017 · 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…
Teva Pharmaceuticals USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA · 1090 Horsham Rd · North Wales, PA · 19454-1505
Is this the product you have?
- 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 byActavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA
- Distributed byActavis Pharma, Inc. Parsippany, NJ 07054 USA
- Lot codes and dates
- Lot Numbers
a) 1089376A1089382A1095210M1117768M1117769AExp. 11/171128452A1128453A1137658A1154207A1156087AExp. 03/18b) 1089379A1091533M1125206AExp. 11/171128456A1147665A1154208A1156088AExp. 03/18
- Lot Numbers
- Amount recalled
- 140,993 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
This product could cause temporary or reversible health problems — stop using it.
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