FDA recall D-1031-2022

Mckesson Medical-Surgical Inc. Corporate Office · Class II · drug

Product

Sterile Water for Injection USP, 2000 mL, Rx only, Baxter Healthcare Corp., NDC 0338-0013-06

Reason for recall

cGMP deviations: Temperature abuse

Distribution

USA nationwide.

Key facts

Status
Terminated
Initiation date
2022-04-13
Report date
2022-06-15
Termination date
2023-11-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1031-2022