FDA Drug recall D-0535-2023
Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for: Focus Health…
- FDA Drug
- Class III
- ongoing
- Published 2023-04-19
On 2023-04-19 the FDA classified a Class III recall of Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for: Focus Health… by Focus Health Group, citing labeling; Incorrect NDC number on outer carton of product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0535-2023 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2023-03-16 |
| Published | 2023-04-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Focus Health Group |
| Distribution | US |
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
Labeling; Incorrect NDC number on outer carton of product.
Identifiers
| ndc | 24357-011-13 |
|---|---|
| ndc | 42023-159-25 |
| ndc | 68599-5804-1 |
| code_info | Lot numbers: 57943EMS, exp 5/31/2023; 56276EMS, exp 4/30/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0535-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.