FDAHealthSeptember 25, 2024
Fresenius Kabi Compounding, LLC — 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
⚠️ cGMP violations
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 25, 2024
Product was distributed to 125 direct accounts nationwide.
What's affected?
- Product
- 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
- Lot code
- C274-000038958
Additional details
Lot # C274-000038958, exp. date 17-Oct-24 C274-000039206, exp. date 23-Oct-24
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 753 bags.
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