FDA recall D-0445-2022
Edge Pharma, LLC · Class II · 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
Reason for recall
CGMP Deviations
Distribution
nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2021-12-06
- Report date
- 2022-02-02
- Termination date
- 2023-06-07
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Colchester, VT, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0445-2022