FDA Drug recall D-0445-2022
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.,…
- FDA Drug
- Class II
- terminated
- Published 2022-02-02
On 2022-02-02 the FDA classified a Class II recall of 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.,… by Edge Pharma, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0445-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-06 |
| Published | 2022-02-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Edge Pharma |
| Distribution | US |
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
CGMP Deviations
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0445-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.