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.
Recall Number: D-0661-2020
Firm: AVKARE Inc.
Classification: Class II
Status: Terminated
Report Date: 20200122
Initiation Date: 20200107
Termination Date: 20210714
Reason for Recall
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
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.