FDA recall D-0993-2022
Mckesson Medical-Surgical Inc. Corporate Office · Class II · drug
Product
EPI-PEN 2-PAK (epinephrine injection, USP), Single-Dose Auto-Injectors 0.3 mg, Rx only, Manufactured for: Mylan Specialty LP., NDC 49502-500-02
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-0993-2022