Recalls / Class II

Class IID-0362-2024

Product

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

Affected lot / code info

Lot #:2331123, Exp:28-Feb-24; 2331298, Exp: 24-Mar-24.

Why it was recalled

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

Recalling firm

Firm

Denver Solutions, LLC DBA Leiters Health

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

13796 Compark Blvd, Englewood, Colorado 80112-7145

Distribution

Quantity

10,020 vials

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2024-02-20

FDA classified

2024-02-29

Posted by FDA

2024-03-06

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0362-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.