CLASS II Drug recall · Reported 30 Oct 2024 · FDA Enforcement Report
EPINEPHrine 9% Sodium Chloride Injection USP, 8 mg per Single Dose recalled
Fresenius Kabi Compounding is recalling EPINEPHrine 9% Sodium Chloride Injection USP, 8 mg per Single Dose, distributed nationwide in the US. The recall was initiated on 25 Sep 2024 and the FDA has classified it as Class II.
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-0022-2025
- FDA event ID
- 95427
- Recalling firm
- Fresenius Kabi Compounding, Canton, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Sep 2024
- FDA classified
- 21 Oct 2024
- Reported
- 30 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Allergy Medication
Timeline
| 25 Sep 2024 | Recall initiated by company | |
| 21 Oct 2024 | Classified by FDA | +26 days |
| 30 Oct 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP violations
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58
Where it was distributed
Product was distributed to 125 direct accounts nationwide.
Questions about this recall
Is EPINEPHrine 9% Sodium Chloride Injection USP, 8 mg per Single Dose recalled?
Yes. Fresenius Kabi Compounding recalled EPINEPHrine 9% Sodium Chloride Injection USP, 8 mg per Single Dose on 25 Sep 2024. The recall is Class II and its status is Terminated. Recall number D-0022-2025.
Why was it recalled?
cGMP violations
Which lots are affected?
Lot # C274-000038958, exp. date 17-Oct-24 C274-000039206, exp. date 23-Oct-24
Where was it sold?
Product was distributed to 125 direct accounts nationwide.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fresenius Kabi Compounding
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | acyclovir sodium, 200 mg, 200mg added to recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
| Drug | CLASS II | vancomycin HCl added to, 9% Sodium Chloride Injection recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
| Drug | CLASS II | vancomycin HCl added to, 9% Sodium Chloride Injection recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
| Drug | CLASS II | ketamine HCl, 1,000 mg, 1,000 mg per (10 mg per mL) recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
| Drug | CLASS II | thiamine HCl, 500 mg, 500 mg added to recalled | Fresenius Kabi Compounding | Sterility | Nationwide |