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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

Medivant Healthcare Lidocaine and Epinephrine Recalled for Subpotency

Agency Publication Date: July 10, 2024
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Summary

Medivant Healthcare is recalling 12,525 10 mL vials of Lidocaine HCL Injection and Epinephrine HCl due to subpotency issues. The epinephrine in the medication was found to have reduced efficacy, which means it may not work as effectively as intended during medical procedures. If you have concerns about treatment involving this medication, please contact your healthcare provider or pharmacist.

Risk

The reduced potency of epinephrine can lead to a shorter duration of anesthesia or increased bleeding during procedures, which may require additional medical intervention.

What You Should Do

  1. The recalled product is Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000 in 10 ml Single Dose Vials, compounded by Medivant Healthcare.
  2. Identify the affected vials by checking for lot number 2311003 with an expiration date of 11/13/2024, NDC 81483-0038-0, and UPC 381483003802.
  3. Stop using the recalled product immediately.
  4. Contact TAILSTORM HEALTH INC or your distributor to arrange for the return of the recalled product.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

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: Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000 (10 ml)by Medivant Healthcare
Variants: 10 ml Single Dose Vial, USP 2% 200mg/10mL (20mg/mL), 1:200,000
UPC Codes:
381483003802
Lot Numbers:
2311003 (Exp 11/13/2024)
NDC:
81483-0038-0

Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94930
Status: Active
Manufacturer: TAILSTORM HEALTH INC
Sold By: Wholesalers; Medical facilities; Hospitals
Manufactured In: United States
Units Affected: 12,525 10 mL vials
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.