FDA recall D-1077-2022

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

Product

Propofol Injectable Emulsion, USP, 200 mg/ 20 mL (10 mg/mL), packaged in a) 50 mL vial, in packs of 20 (NDC 00591-2136-51), b) 100 mL vial, in packs of 10 (NDC 00591-2136-68), Rx only, MFG: Teva Pharma USA

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-1077-2022