Recalls / Class III
Class IIID-0535-2023
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
- Brand name
- Epinephrine Professional
- Generic name
- Epinephrine And Isopropyl Alcohol
- Route
- Intramuscular, Subcutaneous
- NDC
- 24357-011
- FDA application
- NDA204200
- Affected lot / code info
- Lot numbers: 57943EMS, exp 5/31/2023; 56276EMS, exp 4/30/2024
Why it was recalled
Labeling; Incorrect NDC number on outer carton of product.
Recalling firm
- Firm
- Focus Health Group Inc
- Manufacturer
- Focus Health Group
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5802 Kingston Pike, N/A, Knoxville, Tennessee 37919-6339
Distribution
- Quantity
- 246 kits
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-03-16
- FDA classified
- 2023-04-13
- Posted by FDA
- 2023-04-19
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0535-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.