Drug product
Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13
D-0631-2021
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 88091
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10 cartons
- Official record key
drug-enforcement:D-0631-2021
Official wording
Reason: Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Code information: Lot: 38617 Exp. 10/2022
Distribution pattern: Distributed in Los Angeles California
Derived failure modes
-
Potency or specification failure
Out of specification