FDA recall D-1000-2022

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

Product

Bupivacaine HCl Injection, Multi dose vial, 0.25%, 50 mL/2.5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0249-50

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-1000-2022