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.
Product description
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 numbers, UPCs & expiration codes
Lot #: 6122760, 6122761, exp 08/2021; 6122762, exp 09/2021; 6123883, exp 03/2022
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1391-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 13, 2020
- FDA report date
- Jul 22, 2020
- Quantity
- 63,067 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-1391-2020, exactly as published.
Show all FDA fields
- City
- Lake Zurich
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 86018
- Address
- 3 Corporate Dr
- Code information
- Lot #: 6122760, 6122761, exp 08/2021; 6122762, exp 09/2021; 6123883, exp 03/2022
- Postal code
- 60047-8930
- Report date
- Jul 22, 2020
- Product type
- Drugs
- Recall number
- D-1391-2020
- Classification
- Class III
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 63,067 vials
- Termination date
- Aug 19, 2022
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jul 13, 2020
- Initial firm notification
- Letter
- Center classification date
- Jul 16, 2020