FDA recall D-1069-2022

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

Product

Medroxyprogesterone acetate injectable suspension, USP, 150 mg/mL, 1 mL vials, packaged in a) single dose vial (NDC 0703-6801-01), b) 25-count box single dose vials (NDC 0703-6801-04), 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-1069-2022