Drug recall D-1391-2020
Product
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
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.
Lots and codes
Lot #: 6122760, 6122761, exp 08/2021; 6122762, exp 09/2021; 6123883, exp 03/2022
Recall details
- Recalling firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Quantity
- 63,067 vials
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 13, 2020
- Terminated
- August 19, 2022
Related products
- Fosaprepitant – drug information
- NDC 63323-972 Fosaprepitant · Fosaprepitant Dimeglumine 150 mg/5mL · Fresenius Kabi USA, LLC