Drug product
Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16
D-0007-2023
Product summary
- Event
- Event 90868
- Status
- Completed
- Classification
- Class III
- Quantity
- 2,838 ampules
- Official record key
drug-enforcement:D-0007-2023
Official wording
Reason: Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Code information: Lot # ACB101, Exp 03/2023
Distribution pattern: USA nationwide
Derived failure modes
-
Potency or specification failure
Out of specification