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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 Epinephrine-Lidocaine HCl Recalled for Lack of Sterility Assurance

Agency Publication Date: May 30, 2024
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Summary

Imprimis NJOF, LLC has recalled 74,440 units of Epinephrine-Lidocaine HCl (0.25 mg/mL and 7.5 mg/mL) Preservative-Free 1mL Single-Use vials used for intraocular injection. This voluntary recall was initiated due to a lack of assurance of sterility in the manufacturing process. Patients or providers with questions should contact their healthcare professional or the manufacturer directly.

Risk

A lack of sterility assurance in a drug intended for injection into the eye can lead to serious infections, inflammation, and potential permanent vision loss. No specific injuries have been reported in the recall data.

What You Should Do

  1. This recall affects Epinephrine-Lidocaine HCl (0.25 mg/mL and 7.5 mg/mL) Preservative-Free 1mL Single-Use vials for Intraocular Injection produced by Imprimis NJOF, LLC (NDC 71384-640-01).
  2. Check the lot number and expiration date printed on the vial label or carton. Affected lot numbers include 23JUL025, 23SEP012, 23OCT015, 23OCT020, 23OCT026, 23NOV030, 23DEC026, 24JAN011, 24FEB033, and 24JAN050. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange for the return of any remaining inventory.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information or to report a problem.

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: Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection
Variants: 0.25 mg/mL and 7.5 mg/mL, Preservative-Free, 1mL Single-Use vial
Lot Numbers:
23JUL025 (Exp. Date 7/17/2024)
23SEP012 (Exp. Date 7/11/2024)
23OCT015 (Exp. Date 7/20/2024)
23OCT020 (Exp. Date 7/25/2024)
23OCT026 (Exp. Date 8/22/2024)
23NOV030 (Exp. Date 8/29/2024)
23DEC026 (Exp. Date 9/29/2024)
24JAN011 (Exp. Date 7/21/2024)
24FEB033 (Exp. Date 8/24/2024)
24JAN050 (Exp. Date 8/30/2024)
NDC:
71384-640-01

Recall #: D-0519-2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94553
Status: Active
Manufacturer: Imprimis NJOF, LLC
Sold By: Hospitals; Surgical Centers; Wholesalers
Manufactured In: United States
Units Affected: 74,440 units
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.