CLASS III ONGOING Drug recall · Reported 19 Apr 2023 · FDA Enforcement Report
Epinephrine Professional EMS kits recalled by Focus Health Group
Focus Health Group is recalling Epinephrine Professional EMS kits, distributed nationwide in the US. The recall was initiated on 16 Mar 2023 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0535-2023
- FDA event ID
- 91911
- Recalling firm
- Focus Health Group, Knoxville, TN
- Manufacturer
- Focus Health Group
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 16 Mar 2023
- FDA classified
- 13 Apr 2023
- Reported
- 19 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Allergy Medication
Timeline
| 16 Mar 2023 | Recall initiated by company | |
| 13 Apr 2023 | Classified by FDA | +28 days |
| 19 Apr 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling; Incorrect NDC number on outer carton of product.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Labeling; Incorrect NDC number on outer carton of product.
Which lots are affected?
Lot numbers: 57943EMS, exp 5/31/2023; 56276EMS, exp 4/30/2024
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Epinephrine recalls
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Epinephrine Injection, USP, 30 mg/ (1mg/mL)-Multiple-Dose Vial recalledEpinephrine | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS III | Epinephrine Injection, USP, 1mg/mL single-dose vial recalledEpinephrine | Fresenius Kabi USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Epinephrine Injection, USP, 1 mg/ (0.1 mg/mL) recalledEpinephrine | International Medication Systems | Sterility | Nationwide |
| Drug | CLASS II | Adrenalin (epinephrine) Injection 1mg/mL single dose vial recalledAdrenalin | Henry Schein Inc. and Glove Club HSI Gloves | Packaging Defects | Nationwide |
| Drug | CLASS II | EPINEPHrine, 2 mg added to dextrose 5%, Concentration = 8 mcg/mL, IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |