March 2023 FDA Recall Epinephrine Professional by Focus Health Group Inc
D-0535-2023 - Labeling; Incorrect NDC number on outer carton of product.
This Class III drug recall was voluntarily initiated by Focus Health Group Inc on March 16, 2023 for the product Epinephrine Professional. The FDA reported the reason for recall as labeling; incorrect ndc number on outer carton of product.. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0535-2023
Labeling; Incorrect NDC number on outer carton of product.
03-16-2023
04-19-2023
246 kits
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Focus Health Group Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
