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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Epinephrine-Lidocaine HCl Injection Recalled for Subpotency

Agency Publication Date: October 5, 2023
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Summary

Imprimis NJOF, LLC has voluntarily recalled 364 bags of Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection. This preservative-free injection, used for eye surgery, is being recalled because testing found it to be subpotent, meaning it does not contain the required level of epinephrine. No incidents or injuries related to this recall have been reported.

Risk

Because the medication is subpotent, it may not be as effective as intended during surgical procedures, which could potentially impact patient care and surgical outcomes.

What You Should Do

  1. This recall affects Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection with NDC 71384-640-01 and lot number 23APR018.
  2. Stop using the recalled product.
  3. Contact the manufacturer, Imprimis NJOF, LLC, at (844) 446-6979 or your distributor to arrange for the return of the medication.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional information regarding this recall.

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 (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection
Variants: Preservative Free, 1mL Single Use
Lot Numbers:
23APR018 (Exp 17APR2024)
NDC:
71384-640-01

Compounded on 24APR2023. Distributed for office use only; not for resale. Shipped in bags containing 20 glass amber vials.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93160
Status: Resolved
Manufacturer: Imprimis NJOF, LLC
Sold By: Office use only
Manufactured In: United States
Units Affected: 364 bags (1 mL filled in 2 mL glass amber vials; 20 vials shipped in a bag)
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 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.