D-0661-2020 Class II Terminated
FDA drug recall D-0661-2020 was initiated by AVKARE Inc. on January 7, 2020 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: High out of specification results for related compounds. The recall status is terminated (terminated July 14, 2021). Affected quantity: 3,989 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- January 22, 2020
- Initiation Date
- January 7, 2020
- Termination Date
- July 14, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,989 cartons
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.
Distribution Pattern
Nationwide in the USA.
Code Information
Lots: 25246, Exp. 02/2021; 24532, Exp. 10/2020; 23647, Exp. 06/2020