FDA recall D-0415-2022
Edge Pharma, LLC · Class II · drug
Product
Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1545-05
Reason for recall
Lack of Assurance of Sterility
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-0415-2022