Why it was recalled
Labeling; Incorrect NDC number on outer carton of product.
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 numbers, UPCs & expiration codes
Lot numbers: 57943EMS, exp 5/31/2023; 56276EMS, exp 4/30/2024
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0535-2023
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Mar 16, 2023
- FDA report date
- Apr 19, 2023
- Quantity
- 246 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Focus Health Group Inc
Original FDA data
Every field from FDA enforcement report D-0535-2023, exactly as published.
Show all FDA fields
- City
- Knoxville
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 91911
- Address
- 5802 Kingston Pike
- Code information
- Lot numbers: 57943EMS, exp 5/31/2023; 56276EMS, exp 4/30/2024
- Postal code
- 37919-6339
- Report date
- Apr 19, 2023
- Product type
- Drugs
- Recall number
- D-0535-2023
- Classification
- Class III
- Recalling firm
- Focus Health Group Inc
- Product quantity
- 246 kits
- Reason for recall
- Labeling; Incorrect NDC number on outer carton of product.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 16, 2023
- Initial firm notification
- Letter
- Center classification date
- Apr 13, 2023