Leiters Health recalls 10 vials of moxifloxacin 1 mg/mL solution for intracameral injection due to potential label mix-up with 5 mg/mL concentration. This affects prescription-only products sold in the US.
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Leiters Health is recalling 10 vials of moxifloxacin 1 mg/mL solution for intracameral injection because vials labeled as 1 mg/mL might actually contain 5 mg/mL. This could lead to incorrect dosing if used without proper verification.
Vials labeled as 1 mg/mL may contain 5 mg/mL instead. This labeling error could cause incorrect dosing if the medication is used without verifying the concentration.
Prescription patients using moxifloxacin for eye injections. Those with the specific Leiters Health product code 13796 are most at risk.
Check for Leiters Health product code 13796 on the vial. The product is a prescription-only solution for intracameral injection, sold in 10-vial cartons with NDC 71449-096-42.
Check the vial label for the concentration (1 mg/mL or 5 mg/mL) before use.
The product is safe if you verify the concentration on the label before use. However, the labeling error means you should not assume the concentration is correct.
Look for Leiters Health product code 13796 on the vial, which is a prescription-only solution for intracameral injection.
Verify the concentration on the label before use. If you are unsure, contact Leiters Health at (800) 292-6772.
We’ve drafted a message you can send Leiters Health to request your refund or repair — edit it as you like.
Subject: Recall D-0288-2022 — Leiters Health Leiters Health Hello, I own a Leiters Health that is covered by recall D-0288-2022 from Leiters Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
