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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
- Affected units
- 246
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.
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