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
10,020 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 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42
Code / lot info
Lot #:2331123, Exp:28-Feb-24; 2331298, Exp: 24-Mar-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.