AVKARE Inc. recalls Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulask…
- Recall date
- January 7, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0661-2020
- FDA classification
- Class II
- Brand / firm
- AVKARE Inc.
- Sold / distributed
- Nationwide in the USA.
Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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