Drug 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
D-0535-2023
Product summary
- Event
- Event 91911
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 246 kits
- Official record key
drug-enforcement:D-0535-2023
Official wording
Reason: Labeling; Incorrect NDC number on outer carton of product.
Code information: Lot numbers: 57943EMS, exp 5/31/2023; 56276EMS, exp 4/30/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling; Incorrect