Drug product
Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42
D-0362-2024
Product summary
- Event
- Event 94071
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10,020 vials
- Official record key
drug-enforcement:D-0362-2024
Official wording
Reason: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Code information: Lot #:2331123, Exp:28-Feb-24; 2331298, Exp: 24-Mar-24.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter