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Denver Solutions, LLC DBA Leiters Health recalls Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose

Recalled March 6, 2024 · FDA recall D-0361-2024 · Denver Solutions, LLC

Hazard
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. · FDA Class II
Units
40,090 vials
Sold at
Nationwide in the USA

Description

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

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
Manufacturer(s)
Denver Solutions, LLC DBA Leiters Health

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Denver Solutions, LLC DBA Leiters Health recalls Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose | RecallWatchUSA