FDA recall D-0446-2021
Cardinal Health Inc. · Class II · drug
Product
TOBRAMY/DEX 0.3-0.1% 10ML OPTH; NDC/UPC 24208029510; RX; DROPS
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-0446-2021