Fresenius Kabi Compounding, LLC recalls Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Service
Recalled October 30, 2024 · FDA recall D-0014-2025 · Fresenius Kabi Compounding
Hazard
CGMP violations · FDA Class II
Units
1313 bags
Sold at
Product was distributed to 125 direct accounts nationwide.
Description
CGMP violations
Product
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58
Manufacturer(s)
Fresenius Kabi Compounding, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →