Class III
Terminated
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
- Company
- Fresenius Kabi Usa, Llc
- Recall Initiated
- July 13, 2020
- Posted
- July 22, 2020
- Recall Number
- D-1391-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 63,067 vials
- Firm Location
- Lake Zurich, IL, United States
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
Lot / Code Info
Lot #: 6122760, 6122761, exp 08/2021; 6122762, exp 09/2021; 6123883, exp 03/2022
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