Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, ...

FDA Drug Recall #D-1391-2020 — Class III — July 13, 2020

Recall Summary

Recall Number D-1391-2020
Classification Class III — Low risk
Date Initiated July 13, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Fresenius Kabi USA, LLC
Location Lake Zurich, IL
Product Type Drugs
Quantity 63,067 vials

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.

Distribution Pattern

Nationwide within the United States

Lot / Code Information

Lot #: 6122760, 6122761, exp 08/2021; 6122762, exp 09/2021; 6123883, exp 03/2022

Other Recalls from Fresenius Kabi USA, LLC

Recall # Classification Product Date
D-0424-2026 Class II 0.45% Sodium Chloride Injection, USP, 1.125 gra... Mar 11, 2026
D-0428-2026 Class II 0.9% Sodium Chloride Injection, USP, (4,500 mg ... Mar 11, 2026
D-0427-2026 Class II 0.9% Sodium Chloride Injection, USP, (2,250 mg ... Mar 11, 2026
D-0426-2026 Class II 0.9% Sodium Chloride Injection, USP, 0.9% (900 ... Mar 11, 2026
D-0434-2026 Class II 0.9% Sodium Chloride Injection, USP 900 mg per ... Mar 11, 2026

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.