Recall D-0535-2023
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
Recall D-0535-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0535-2023 |
| Event ID | 91911 |
| Brand | EPINEPHRINE PROFESSIONAL |
| Generic Name | EPINEPHRINE AND ISOPROPYL ALCOHOL |
| Manufacturer | EPINEPHRINE AND ISOPROPYL ALCOHOL |
| Original Package? | 1 |
| Drug Route | INTRAMUSCULAR |
| Distribution | Nationwide in the USA |
| Quantity | 246 kits |
| Recall Reason | Labeling; Incorrect NDC number on outer carton of product. |
| Drug Classification | Class III |
| Drug Code Info | 20230419 |
| Product NDC | 24357-011 |
| Recall Initiation Date | 20230316 |
| Report Date | 20230419 |
| Classification Date | 20230413 |
| Address | 5802 Kingston Pike Knoxville, TN 37919-6339 United States |
| Recalling Firm | Focus Health Group Inc |
| Initial Notification | Letter |
| Drug Application Number | NDA204200 |
| Structured Product Labeling (SPL ID) | eb6598c3-bb08-32e0-e053-2a95a90a13b5 |
| Structured Product Labeling (SPL Set ID) | 8c502fcc-1b61-7d1f-e053-2a95a90adc46 |
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