Drug product
ActivEyes Altachlore Sodium Chloride Hypertonicity Opthalmic Ointment, 5%, Manufactured by: Altaire Pharmaceuticals Inc. Aquebogue, NY 11931, NDC 59390-184-50
D-0416-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 46345 units
- Official record key
drug-enforcement:D-0416-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: SAP 1/20 3/16/2018 SFI 6/20 8/16/2018 SLA 12/20 1/4/2019 TBM 2/21
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility