Drug product
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.
D-0661-2020
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 84677
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,989 cartons
- Official record key
drug-enforcement:D-0661-2020
Official wording
Reason: Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
Code information: Lots: 25246, Exp. 02/2021; 24532, Exp. 10/2020; 23647, Exp. 06/2020
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
out of specification