Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42

FDA recall notice · announced March 6, 2024 · Denver Solutions, Llc Dba Leiters Health

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42

Reason for recall

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #:2331123, Exp:28-Feb-24; 2331298, Exp: 24-Mar-24.
Quantity: 10,020 vials
Status: Ongoing
Products in this recall event:
- Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42 (D-0363-2024)
- 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)
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.