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Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for...

FDA Recall #D-0661-2020 — Class II — January 7, 2020

Recall #D-0661-2020 Date: January 7, 2020 Classification: Class II Status: Terminated

Product Description

Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-282-13.

Reason for Recall

Failed Impurities/Degradation Specifications: High out of specification results for related compounds.

Recalling Firm

AVKARE Inc. — Pulaski, TN

Classification

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

Product Type

Drugs

Product Quantity

3,989 cartons

Distribution

Nationwide in the USA.

Code Information

Lots: 25246, Exp. 02/2021; 24532, Exp. 10/2020; 23647, Exp. 06/2020

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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