Drug product
Ofloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, Rx only, Altaire Pharmaceuticals, Inc., NDC 59390-140-05
D-0436-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 102,939 units
- Official record key
drug-enforcement:D-0436-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: 17244 8/19 18057 3/20 518307 12/20
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility