FDA recall D-0831-2022

SCA Pharmaceuticals · Class II · drug

Product

Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44

Reason for recall

CGMP Deviations

Distribution

Product was distributed nationwide within the United States

Key facts

Status
Terminated
Initiation date
2022-04-25
Report date
2022-05-11
Termination date
2022-09-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Windsor, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0831-2022