Medications & Supplements/Prescription Drugs

Moxifloxacin - Bromfenac Ophthalmic Solution Recalled for Subpotency

Agency Publication Date: August 21, 2023

Summary

Imprimis NJOF, LLC is recalling 2,683 bottles of Moxifloxacin - Bromfenac Sterile Ophthalmic Solution (0.5% / 0.075%) because the levels of Bromfenac in the medicine were found to be below required specifications. This subpotency means the medication may not be as effective as intended for patients. No injuries or incidents have been reported to date in connection with this recall.

Risk

The eye drops contain less of the active ingredient Bromfenac than is required, which may result in the medication being less effective at treating the patient's condition. While the risk to health is considered low, the product does not meet potency standards.

What You Should Do

This recall affects 5mL bottles of Moxifloxacin - Bromfenac Sterile Ophthalmic Solution (0.5% / 0.075%) sold under the Imprimis NJOF, LLC label with NDC 71384-311-05.
Check your medication bottle for lot number 22DEC047 with an expiration date of 9/16/23, or lot number 23FEB057 with an expiration date of 11/24/23.
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 Imprimis NJOF, LLC at 844-446-6979 for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 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

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: Moxifloxacin - Bromfenac Sterile Ophthalmic Solution (5mL bottle)

Variants: 0.5% / 0.075%, 5mL bottle

Lot Numbers:

22DEC047 (Exp 9/16/23)

23FEB057 (Exp 11/24/23)

NDC:

71384-311-05

Manufactured by Imprimis NJOF, LLC in Ledgewood, NJ.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92848

Status: Resolved

Manufacturer: Imprimis NJOF, LLC

Manufactured In: United States

Units Affected: 2,683 bottles

Distributed To: Nationwide

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 · 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.

Summary

What You Should Do

This recall affects 5mL bottles of Moxifloxacin - Bromfenac Sterile Ophthalmic Solution (0.5% / 0.075%) sold under the Imprimis NJOF, LLC label with NDC 71384-311-05.

Check your medication bottle for lot number 22DEC047 with an expiration date of 9/16/23, or lot number 23FEB057 with an expiration date of 11/24/23.

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 Imprimis NJOF, LLC at 844-446-6979 for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.