Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single…
BE PHARMACEUTICALS AG · Lack of Sterility Assurance: Aseptic process simulation failure.
- Status
- Terminated
- City
- Zug
- State
- N/A
- Country
- Switzerland
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 93747
- Recalling firm
- BE PHARMACEUTICALS AG
- Address 1
- Bundesstrasse 3
- Address 2
- N/A
- Postal code
- N/A
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
- Recall number
- D-0262-2024
- Product quantity
- 22,176 Vials
- Reason for recall
- Lack of Sterility Assurance: Aseptic process simulation failure.
- Recall initiation date
- 20240110
- Center classification date
- 20240125
- Termination date
- 20250610
- Report date
- 20240131
- Code info
- lot #13D012AA, Exp: 08/31/2025
- 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.
- Harmonized identifiers (openFDA)
- Application number
- ANDA212309
- Brand name
- FOSAPREPITANT
- Generic name
- FOSAPREPITANT
- Manufacturer name
- BE Pharmaceuticals Inc.
- Product NDC
- 71839-104
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- FOSAPREPITANT DIMEGLUMINE
- RxCUI
- 1731077
- SPL ID
- 1b1fe4ce-02d6-4ca1-8168-37b099caa434
- SPL set ID
- 21b08b87-70e3-4233-9531-dd6d84eab5d0
- Package NDC
- 71839-104-01
- Is original packager
- true
- Upc
- 0371839104017
- UNII
- D35FM8T64X