Recalling firm
Denver Solutions, LLC DBA Leiters Health
Product type
Drug
Status
Ongoing
Report date
2024-03-06
Distribution
Nationwide in the USA
Firm state
CO
Product quantity
40,090 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason for recall
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Product description
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
Code / lot 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.
Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.