FDA recall D-1055-2022
Mckesson Medical-Surgical Inc. Corporate Office · Class II · drug
Product
Ibuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-5853-61
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-1055-2022