FDA-Drug2020-01-22Class II

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.

AVKARE Inc.
Hazard

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

Sold states
Nationwide in the USA.
Affected count
3,989 cartons
Manufactured in
615 N 1st St, Pulaski, TN, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0661-2020

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