Drug product
Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe for Oral Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1132-03
D-0445-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 757 syringes
- Official record key
drug-enforcement:D-0445-2022
Official wording
Reason: CGMP Deviations
Code information: 10-2021-11@6 01-09-2022 10/27/21 - 11/16/21 11-2021-01@8 01-30-2022 11/16/21 - 12/01/21
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations