Fresenius Kabi Recalls Fosaprepitant Injection Due to Labeling Error
Fresenius Kabi USA, LLC is recalling 63,067 vials of Fosaprepitant for Injection because carton labels and product inserts incorrectly state the amount of the excipient edetate disodium (EDTA).
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding an excipient.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 63,067 vials of Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial. The recall is due to a labeling error where the carton label and product insert incorrectly state the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.
The affected product is identified by NDC 63323-972-10. The recall includes vials from Lot # 6122760 and 6122761 (exp 08/2021), Lot # 6122762 (exp 09/2021), and Lot # 6123883 (exp 03/2022). The product was distributed nationwide within the United States.
This is a Class III recall, which indicates that the product is not likely to cause adverse health consequences. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above.
The recalled product
- Product
- FOSAPREPITANT (FOSAPREPITANT)
- Brand
- FOSAPREPITANT
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 63,067
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #: 6122760
- 6122761
- exp 08/2021
- 6122762
- exp 09/2021
- 6123883
- exp 03/2022
UPCs (1)
- 0363323972103
Distribution
Distributed nationwide across the United States.
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