The Recall Desk
LowFDA (Drugs)·D-0535-2023·Announced 2023-04-19

Prescription Epinephrine Kits Recalled for Incorrect NDC Number on Carton

Focus Health Group is recalling 246 kits of Epinephrine Professional nationwide due to an incorrect NDC number printed on the outer carton. The labeling error does not affect the drug's safety or effectiveness.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: FDA Class III recall for a packaging labeling error (incorrect NDC number) with no reported health hazard, illness, or injury. Labeling and documentation issues are classified as Low severity per the rubric.

Plain-English summary

Focus Health Group Inc is recalling Epinephrine Professional kits distributed nationwide. The recall affects 246 kits with lot numbers 57943EMS (expiration 5/31/2023) and 56276EMS (expiration 4/30/2024).

The kits are being recalled due to incorrect labeling: the outer carton displays an incorrect National Drug Code (NDC) number.

The affected product was distributed nationwide in the United States.

Healthcare providers and medical facilities that received this product should contact Focus Health Group Inc regarding the labeling issue.

The recalled product

Product
EPINEPHRINE PROFESSIONAL (EPINEPHRINE AND ISOPROPYL ALCOHOL)
Brand
EPINEPHRINE PROFESSIONAL
Manufacturer
Focus Health Group Inc
Category
Drug — Emergency Medication
Hazard
  • mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot numbers: 57943EMS
  • exp 5/31/2023
  • 56276EMS
  • exp 4/30/2024

Distribution

Distributed nationwide across the United States.

Related recalls

Same category