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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Leiters Health Moxifloxacin Injection Recalled for Labeling Mix-up

Agency Publication Date: December 17, 2021
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Summary

Denver Solutions, LLC (DBA Leiters Health) is recalling 1,440 vials of Moxifloxacin, a medication used for injections into the eye during surgery. The recall was initiated because vials labeled as containing a 1 mg/mL concentration may actually contain a 5 mg/mL concentration, which is five times the labeled dose. No injuries or incidents have been reported to date, but the higher dosage could cause harm if administered.

Risk

The incorrect labeling results in patients receiving a much higher dose of medication than intended, which can cause toxic effects to the sensitive tissues of the eye. Administering 5 mg/mL instead of 1 mg/mL significantly increases the risk of eye toxicity.

What You Should Do

  1. This recall involves Moxifloxacin injection (1 mg/mL, 1mL in 2mL vial) sold in 10-vial cartons under the Leiters Health brand, identifiable by NDC 71449-096-42 and Lot 2130958 with an expiration date of 03/31/2022.
  2. Stop using the recalled product immediately.
  3. Contact Leiters Health or your distributor to arrange for the return of any remaining affected vials.
  4. Contact Leiters Health directly at (800) 292-6772 for additional instructions regarding this recall.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for further assistance or questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Moxifloxacin Injection (1 mg/mL)
Variants: 1mL in 2mL vial, 10 vials/carton, Rx only
Lot Numbers:
2130958 (Exp 03/31/2022)
NDC:
71449-096-42

Solution for intracameral injection.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89136
Status: Resolved
Manufacturer: Denver Solutions, LLC DBA Leiters Health
Sold By: Leiters Health; Direct distribution to surgical centers or wholesalers
Manufactured In: United States
Units Affected: 1440 vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.