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
Reported: July 22, 2020 Initiated: July 13, 2020 #D-1391-2020
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
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.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 63,067 vials
- Distribution
- Nationwide within the United States
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fresenius Kabi USA, LLC. Units affected: 63,067 vials.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 22, 2020. Severity: Low. Recall number: D-1391-2020.
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