Recalls / Class III
Class IIID-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
- Brand name
- Fosaprepitant
- Generic name
- Fosaprepitant
- Active ingredient
- Fosaprepitant Dimeglumine
- Route
- Intravenous
- NDC
- 63323-972
- FDA application
- ANDA206197
- Affected lot / code info
- Lot #: 6122760, 6122761, exp 08/2021; 6122762, exp 09/2021; 6123883, exp 03/2022
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.
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, N/A, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 63,067 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-07-13
- FDA classified
- 2020-07-16
- Posted by FDA
- 2020-07-22
- Terminated
- 2022-08-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1391-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.