Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe for Oral...
FDA Recall #D-0445-2022 — Class II — December 6, 2021
Product Description
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
Recalling Firm
Edge Pharma, LLC — Colchester, VT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
757 syringes
Distribution
nationwide
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated