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.
Reported: January 31, 2024 Initiated: January 10, 2024 #D-0262-2024
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.
Reason for Recall
Lack of Sterility Assurance: Aseptic process simulation failure.
Details
- Recalling Firm
- BE PHARMACEUTICALS AG
- Units Affected
- 22,176 Vials
- Distribution
- Nationwide in the USA
- Location
- Zug, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by BE PHARMACEUTICALS AG. Units affected: 22,176 Vials.
Why was this product recalled? ▼
Lack of Sterility Assurance: Aseptic process simulation failure.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 31, 2024. Severity: Moderate. Recall number: D-0262-2024.
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