FDA recall D-1562-2020

Edge Pharma, LLC · Class II · drug

Product

Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1458-01

Reason for recall

Labeling: Label Error on Declared Strength

Distribution

WI

Key facts

Status
Terminated
Initiation date
2020-07-02
Report date
2020-09-16
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-1562-2020