FDA-Drug2024-10-30Class II

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

Fresenius Kabi Compounding, LLC
Hazard

cGMP violations

Sold states
Product was distributed to 125 direct accounts nationwide.
Affected count
753 bags
Manufactured in
20 Dan Rd, N/A, Canton, MA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0022-2025

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