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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

Imprimis NJOF Sterile Ophthalmic Solution Recalled for Subpotency

Agency Publication Date: April 29, 2024
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Summary

Imprimis NJOF, LLC is recalling 3,320 bottles of Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution (1%, 0.5%, 0.075%). This medication is being recalled because it was found to be subpotent, which means it contains less than the required amount of active ingredients. The affected bottles are 8mL in size and were compounded by Imprimis NJOF, LLC in Ledgewood, New Jersey.

Risk

A subpotent drug may not work as effectively as intended, potentially failing to treat the underlying condition for which it was prescribed. This could lead to inadequate management of inflammation or infection in the eye.

What You Should Do

  1. The recalled product is Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution (1%, 0.5%, 0.075%) in 8mL bottles, identified by NDC 71384-340-08 and lot number 23JUN031 with an expiration date of 07/03/2024.
  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.

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 Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution (8mL)
Variants: 1%, 0.5%, 0.075%
Lot Numbers:
23JUN031 (Exp. 07/03/2024)
NDC:
71384-340-08

Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94378
Status: Active
Manufacturer: Imprimis NJOF, LLC
Manufactured In: United States
Units Affected: 3320 bottles
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.