Why it was recalled
Lack of Sterility Assurance: Aseptic process simulation failure.
Product description
Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial, Rx Only, Distributed by BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511, Made in India, NDC 71839-104-01.
Lot numbers, UPCs & expiration codes
lot #13D012AA, Exp: 08/31/2025
Where it was sold
Nationwide in the USA
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-0262-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 10, 2024
- FDA report date
- Jan 31, 2024
- Quantity
- 22,176 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- BE PHARMACEUTICALS AG
Original FDA data
Every field from FDA enforcement report D-0262-2024, exactly as published.
Show all FDA fields
- City
- Zug
- Status
- Terminated
- Country
- Switzerland
- Event ID
- 93747
- Address
- Bundesstrasse 3
- Code information
- lot #13D012AA, Exp: 08/31/2025
- Report date
- Jan 31, 2024
- Product type
- Drugs
- Recall number
- D-0262-2024
- Classification
- Class II
- Recalling firm
- BE PHARMACEUTICALS AG
- Product quantity
- 22,176 Vials
- Termination date
- Jun 10, 2025
- Reason for recall
- Lack of Sterility Assurance: Aseptic process simulation failure.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial, Rx Only, Distributed by BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511, Made in India, NDC 71839-104-01.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 10, 2024
- Initial firm notification
- Letter
- Center classification date
- Jan 25, 2024