Reported Jan 22, 2020 · Terminated

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

AVKARE Inc.

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: AVKARE Inc. · 615 N 1st St · Pulaski, TN · 38478-2403

Is this the product you have?

  • Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only
  • Manufactured forAvKARE, Inc., Pulaski, TN 38478, NDC 50268-282-13
Lot codes and dates
  • Lots
    • 25246
    • Exp. 02/2021
    • 24532
    • Exp. 10/2020
    • 23647
    • Exp. 06/2020
Amount recalled
3,989 cartons

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 14, 2021 · Data as of Sep 19, 6:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.