Medications & Supplements/Prescription Drugs

Imprimis NJOF Sterile Ophthalmic Solution Recalled for Sub-Potency

Agency Publication Date: March 28, 2025

Summary

Imprimis NJOF, LLC is recalling 2,822 bottles of a sterile eye drop solution containing Tropicamide, Proparacaine, Phenylephrine, and Ketorolac. The recall was issued because a stability batch tested as "sub-potent," meaning the medication is weaker than the concentration required by product specifications. If the drug is not at the correct strength, it may not work as intended during medical procedures or treatment.

Risk

Using a sub-potent medication can lead to reduced effectiveness, which may result in inadequate pupil dilation or insufficient pain management during ophthalmic procedures. No injuries or adverse events have been reported to date in connection with this recall.

What You Should Do

This recall affects Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution (1%, 0.5%, 2.5%, 0.5% strengths) sold in 5 mL fill bottles (NDC 71384-733-05).
Identify affected bottles by looking for lot number 24OCT041 with an expiration date of 04/26/2025 printed on the label.
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.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for 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: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution (5 mL fill in 15 mL bottle)

Variants: 1% 0.5% 2.5% 0.5% strength

Lot Numbers:

24OCT041 (Exp 04/26/2025)

NDC:

71384-733-05

Quantity: 2822 bottles affected. Distributed in FL and NY.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96329

Status: Active

Manufacturer: Imprimis NJOF, LLC

Sold By: Pharmacies; Healthcare providers; Hospitals

Manufactured In: United States

Units Affected: 2822 bottles

Distributed To: Florida, New York

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 Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution (1%, 0.5%, 2.5%, 0.5% strengths) sold in 5 mL fill bottles (NDC 71384-733-05).

Identify affected bottles by looking for lot number 24OCT041 with an expiration date of 04/26/2025 printed on the label.

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.

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