Epinephrine Professional EMS — Class III drug recall D-0535-2023
Ongoing recall by Focus Health Group Inc, reported 2023-04-19, distributed nationwide. Labeling; Incorrect NDC number on outer carton of product.
| Recall number | D-0535-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Focus Health Group Inc, Knoxville, TN, United States |
| Recall initiated | 2023-03-16 |
| Classified | 2023-04-13 |
| Reported by FDA | 2023-04-19 |
| Distributed | Nationwide (US) |
| Quantity | 246 kits |
| Reason classes | labeling |
| NDC | 24357-0011, 24357-0011-13, 42023-0159-25, 68599-5804-01 |
| Lot numbers | 56276EMS, 57943EMS |
| Expiration dates | 2023-05-31, 2024-04-30 |
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
Reason for recall
Labeling; Incorrect NDC number on outer carton of product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0535-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.