FDA-Drug2024-10-30Class II

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58

Fresenius Kabi Compounding, LLC
Hazard

cGMP violations

Sold states
Product was distributed to 125 direct accounts nationwide.
Affected count
1631 bags
Manufactured in
20 Dan Rd, N/A, Canton, MA, United States
Products
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0015-2025

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