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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 Recalled for Out of Specification Assay

Agency Publication Date: April 30, 2024
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Summary

Imprimis NJOF, LLC is recalling approximately 15,414 units of Epinephrine-Lidocaine HCl (0.25 mg/mL and 7.5 mg/mL) Preservative-Free, 1 mL single-use vials. The recall was initiated because the product was found to be out of specification for assay, meaning the potency of the medication may not meet required standards. If you have concerns about medical treatments involving this drug, please contact your healthcare provider or pharmacist.

Risk

Incorrect potency of epinephrine or lidocaine could lead to ineffective local anesthesia or an inadequate vasoconstrictor response during medical procedures. No incidents or injuries have been reported to date.

What You Should Do

  1. This recall affects Epinephrine-Lidocaine HCl (0.25 mg/mL and 7.5 mg/mL) Preservative-Free, 1 mL single-use vials with NDC 71384-640-01.
  2. Check your clinical supply or medication inventory for lot numbers 23JUL028 (Exp. Date 8/1/2024) and 23AUG053 (Exp. Date 8/30/2024).
  3. Stop using the recalled product immediately and quarantine any remaining units.
  4. Contact Imprimis NJOF, LLC or your medical distributor directly to arrange for the return of the affected product.
  5. If you have health concerns regarding a procedure where this medication was used, contact your healthcare provider or pharmacist.
  6. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

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 (1 mL)by Imprimis NJOF, LLC
Variants: Preservative-Free, 1 mL Single-Use vial, Rx only
Lot Numbers:
23JUL028 (Exp. Date 8/1/2024)
23AUG053 (Exp. Date 8/30/2024)
NDC:
71384-640-01

Quantity affected: 15,414 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94372
Status: Active
Manufacturer: Imprimis NJOF, LLC
Sold By: Hospital and clinical distributors
Manufactured In: United States
Units Affected: 15,414 units
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.