Drug product
Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42
D-0361-2024
Product summary
- Event
- Event 94071
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 40,090 vials
- Official record key
drug-enforcement:D-0361-2024
Official wording
Reason: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Code information: Lot #:2331147, Exp:6-Mar-24; 2331180, Exp: 21-Mar-24; 2331256, Exp: 2-Apr-24; 2331279, Exp: 3-Apr-24; 2331283, Exp: 7-Apr-24; 2331345, Exp: 20-Apr-24; 2331422, Exp: 27-Apr-24; 2331563, Exp: 29-May-24.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter