FDA recall D-1320-2022
Mckesson Medical-Surgical Inc. Corporate Office · Class II · drug
Product
GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.
Reason for recall
CGMP Deviations: products were stored outside the drug label specifications.
Distribution
Nationwide in the USA.
Key facts
- Status
- Terminated
- Initiation date
- 2022-06-29
- Report date
- 2022-08-17
- Termination date
- 2024-02-13
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Richmond, VA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1320-2022