FDA recall D-0426-2022

Edge Pharma, LLC · Class II · drug

Product

Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1458-01

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-0426-2022