Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 ... — FDA record D-0288-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 29, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42
Reason
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Classification
Class II
Recalling firm
Denver Solutions, LLC DBA Leiters Health
Quantity
1440 vials
Agency-reported status
Terminated
Source record identifier
D-0288-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityLot #: 2130958; Expiration Date 03/31/2022

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide within the United States

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Dec 29, 2021
Recall initiation date
Nov 29, 2021
Center classification date
Dec 17, 2021
Termination date
Jul 12, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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