Medications & Supplements/Prescription Drugs

Focus Health Group Epinephrine Kits Recalled for Incorrect NDC Number

Agency Publication Date: April 13, 2023

Summary

Focus Health Group Inc. is recalling 246 kits of Epinephrine Professional EMS (epinephrine 1 mg/mL) convenience kits. This voluntary recall was initiated because the outer carton of the product displays an incorrect National Drug Code (NDC) number. While the medication inside the kit is correct, an incorrect identifier on the packaging can lead to errors during product selection, dispensing, or billing.

Risk

The labeling error involves an incorrect NDC number on the box, which could lead to confusion for healthcare providers or pharmacists when identifying the medication. This poses a low risk of harm, as the medication itself is not defective.

What You Should Do

This recall affects Epinephrine Professional EMS, Epinephrine Convenience Kits (epinephrine 1 mg/mL) manufactured for Focus Health Group.
Identify the affected products by checking for lot numbers 57943EMS (expiring 5/31/2023) or 56276EMS (expiring 4/30/2024). The kits also feature the incorrect NDC number 24357-011-13 on the outer carton.
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 Focus Health Group Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

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: Epinephrine Professional EMS, Epinephrine Convenience Kit (1 mg/mL)

Variants: Rx Only

Lot Numbers:

57943EMS (Exp 5/31/2023)

56276EMS (Exp 4/30/2024)

NDC:

24357-011-13

Quantity affected: 246 kits. The listed NDC is the incorrect number printed on the outer carton.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91911

Status: Active

Manufacturer: Focus Health Group Inc

Sold By: Authorized distributors; EMS suppliers

Manufactured In: United States

Units Affected: 246 kits

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 · 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 Epinephrine Professional EMS, Epinephrine Convenience Kits (epinephrine 1 mg/mL) manufactured for Focus Health Group.

Identify the affected products by checking for lot numbers 57943EMS (expiring 5/31/2023) or 56276EMS (expiring 4/30/2024). The kits also feature the incorrect NDC number 24357-011-13 on the outer carton.

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 Focus Health Group Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.