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.
D-1320-2022
Product summary
- Event
- Event 90553
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 boxes
- Official record key
drug-enforcement:D-1320-2022
Official wording
Reason: CGMP Deviations: products were stored outside the drug label specifications.
Code information: Part# 30065051801
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations