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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

Prednisolone-Moxifloxacin-Bromfenac Eye Drops Recalled for Lack of Sterility

Agency Publication Date: June 8, 2024
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Summary

Imprimis NJOF, LLC is recalling 4,280 boxes of its Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension (1%, 0.5%, 0.075%). These prescription eye drops are being recalled due to a lack of assurance of sterility, which means the product may not be free from microorganisms. Consumers who have used this compounded medication should monitor for signs of infection and contact their doctor or pharmacist.

Risk

A lack of sterility in eye drops poses a risk of bacterial or fungal infection. Such infections can cause serious injury to the eye, including inflammation and potential permanent vision loss.

What You Should Do

  1. The recalled product is Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension (1%, 0.5%, 0.075%) in 5mL bottles, identified by NDC 71384-310-05 and Lot 23NOV018 with an expiration date of 6/17/24.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension (5mL)
Variants: 1%, 0.5%, 0.075%
Lot Numbers:
23NOV018 (Exp. 6/17/24)
NDC:
71384-310-05

Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ. Recall #: D-0548-2024.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94552
Status: Active
Manufacturer: Imprimis NJOF, LLC
Manufactured In: United States
Units Affected: 4,280 boxes
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.