Recalls / Class II

Class IID-0361-2024

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

Affected lot / code info

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.

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

40,090 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-0361-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.