Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufacture
Summary
The FDA issued a Class III for Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, by Focus Health Group Inc. Reason: Labeling; Incorrect NDC number on outer carton of product..
Details
Source
Drug Recall
External ID
D-0535-2023
Action Date
2023-04-19
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot numbers: 57943EMS, exp 5/31/2023; 56276EMS, exp 4/30/2024
Quantity Affected: 246 kits
Reason for Recall
Labeling; Incorrect NDC number on outer carton of product.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-16
Company
Knoxville, TN
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 63 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Focus Health Group Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Focus Health Group Inc have FDA actions?
This is the only FDA action we have on record for Focus Health Group Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0535-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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