Fresenius Kabi USA, LLC is recalling 63,067 vials of Fosaprepitant for Injection (150 mg / vial) because the carton label and product insert incorrectly list the amount of an inactive ingredient. The labels state the product contains 5.4 mg of edetate disodium (EDTA) per vial, when the actual amount is 18.8 mg per vial. This voluntary recall affects specific lots distributed nationwide to healthcare facilities and pharmacies.
While the total amount of EDTA remains within safe limits for patients, the incorrect labeling could lead to confusion or inaccurate dosing calculations by healthcare providers. This labeling error represents a discrepancy in the declared strength of an ingredient on the package.
Healthcare provider consultation and pharmacy refund
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Sources: FDA iRES · Raw API Response
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