Drug product
Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.25 mg / 0.25 mL, 0.25 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678126
D-0075-2020
Product summary
- Event
- Event 83789
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1290 syringes
- Official record key
drug-enforcement:D-0075-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: All lots remaining within expiry.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility