FDAFDA · Food and drugs·Recall number D-1391-2020
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
Published July 22, 2020 · Recall initiated: July 13, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FOSAPREPITANT
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- Nationwide within the United States
- UPC
- 0363323972103
- Lot
- Lot #: 6122760, 6122761, exp 08/2021; 6122762, exp 09/2021; 6123883, exp 03/2022
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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