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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Fosaprepitant for Injection Recalled for Lack of Sterility Assurance

Agency Publication Date: January 25, 2024
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Summary

BE PHARMACEUTICALS AG is voluntarily recalling 22,176 vials of Fosaprepitant (Fosaprepitant for Injection) 150 mg per vial due to a lack of sterility assurance. A failure in the manufacturing process simulation indicates that the sterile environment used to produce the drug may have been compromised. No incidents or injuries have been reported to date. This medication is a sterile powder used intravenously to prevent nausea and vomiting caused by chemotherapy.

Risk

Administering a medication that is not sterile can lead to serious, life-threatening systemic infections. Patients receiving this drug are often undergoing chemotherapy and may have weakened immune systems, making them especially vulnerable to infections.

What You Should Do

  1. This recall affects Fosaprepitant for Injection 150 mg per vial distributed nationwide by BE Pharmaceuticals Inc. under NDC 71839-104-01.
  2. Identify affected vials by checking for lot number 13D012AA with an expiration date of 08/31/2025 printed on the single-dose vial label.
  3. Stop using the recalled product. Contact BE PHARMACEUTICALS AG or your distributor to arrange return of any unused medication.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Fosaprepitant for Injection
Variants: 150 mg per vial, Sterile lyophilized powder, Single Dose Vial, Rx Only
Lot Numbers:
13D012AA (Exp 08/31/2025)
NDC:
71839-104-01

Recall #: D-0262-2024; Distributed by BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93747
Status: Resolved
Manufacturer: BE PHARMACEUTICALS AG
Sold By: BE Pharmaceuticals Inc.
Manufactured In: Switzerland, India
Units Affected: 22,176 Vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.