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Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591...

FDA Recall #D-0069-2018 — Class II — October 25, 2017

Recall #D-0069-2018 Date: October 25, 2017 Classification: Class II Status: Terminated

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.

Recalling Firm

Teva Pharmaceuticals USA — North Wales, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

140,993 bottles

Distribution

Nationwide in the USA and Puerto Rico.

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.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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