Drug product
ActivEyes Altachlore Solution, 15 mL (1/2 FL OZ), Manufactured by Altaire Pharmaceuticals Inc., Aquebogue, NY 11931, NDC 59390-183-13
D-0417-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 22494 units
- Official record key
drug-enforcement:D-0417-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: 18008 1/20 8/13/2018 19050 2/22 3/18/2019 19105 4/22
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility