Drug product
Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-05
D-0461-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 49527 units
- Official record key
drug-enforcement:D-0461-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: 17225 07/19 17247 08/19 18038 02/20 18162 06/20 19014 01/21
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility