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.
Reported: November 8, 2017 Initiated: October 25, 2017 #D-0069-2018
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.
Reason for Recall
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 140,993 bottles
- Distribution
- Nationwide in the USA and Puerto Rico.
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teva Pharmaceuticals USA. Units affected: 140,993 bottles.
Why was this product recalled? ▼
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 8, 2017. Severity: Moderate. Recall number: D-0069-2018.
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