Why it was recalled
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Product description
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.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide in the USA and Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0069-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 25, 2017
- FDA report date
- Nov 8, 2017
- Quantity
- 140,993 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0069-2018, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 78364
- Address
- 1090 Horsham Rd
- Code information
- 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.
- Postal code
- 19454-1505
- Report date
- Nov 8, 2017
- Product type
- Drugs
- Recall number
- D-0069-2018
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 140,993 bottles
- Termination date
- May 2, 2018
- Reason for recall
- Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
- Recall initiation date
- Oct 25, 2017
- Initial firm notification
- Letter
- Center classification date
- Nov 2, 2017