Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10
Check against the official notice below — it lists the full affected range.
Fresenius Kabi USA is recalling Fosaprepitant for Injection, 150 mg per vial, due to a labeling error. The carton label and product insert incorrectly state that each vial contains 5.4 mg of the excipient edetate disodium (EDTA), when the vials actually contain 18.8 mg of EDTA. The recall affects 63,067 vials distributed nationwide, specifically lot numbers 6122760, 6122761, 6122762, and 6123883, with expiration dates ranging from August 2021 to March 2022.
The recall record does not specify what actions consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.
Reason for recall: Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial. Distribution: Nationwide within the United States Quantity: 63,067 vials Lot/code info: Lot #: 6122760, 6122761, exp 08/2021; 6122762, exp 09/2021; 6123883, exp 03/2022
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.