Reported Jul 22, 2020 · Terminated
Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047;…
Fresenius Kabi USA, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Kabi USA, LLC · 3 Corporate Dr · Lake Zurich, IL · 60047-8930
Is this the product you have?
- 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
- Lot codes and dates
Lot #: 61227606122761exp 08/20216122762exp 09/20216123883exp 03/2022
- Amount recalled
- 63,067 vials
Where it was sold
- Nationwide
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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