FDA recall D-0407-2021
Cardinal Health Inc. · Class II · drug
Product
FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution
FL, GA, SC
Key facts
- Status
- Terminated
- Initiation date
- 2021-03-15
- Report date
- 2021-06-02
- Termination date
- 2024-06-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Dublin, OH, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0407-2021