Epinephrine Professional Kit
FDA Recall NDC 24357-011
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Epinephrine Professional (NDC 24357-011). A significant event, classified as Class III, was initiated on Mar 16, 2023 by Focus Health Group. The reported reason for this action was: "Labeling; Incorrect NDC number on outer carton of product."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
March 2023 Class III Recall: Labeling; Incorrect NDC number on outer carton of product.
Recall Number
Class III Ongoing
Labeling; Incorrect NDC number on outer carton of product.
Mar 16, 2023
Apr 19, 2023
246 kits
Recall Profile & Regulatory Data
Event ID
91911
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Focus Health Group Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for: Focus Health Group, 5802 Kingston Pike, Knoxville, TN 37919. Incorrect NDC (kit): 24357-011-13
Batch or Lot Expiration Information
Lot# Lot numbers: 57943EMS, exp 5/31/2023; 56276EMS, exp 4/30/2024
Affected Packages Involved in this Recall
24357-011-13Product
42023-159-25Product
68599-5804-1Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
