Fosaprepitant for Injection 150 mg per vial recall
FDA recall D-0262-2024 · initiated Jan 10, 2024
BE PHARMACEUTICALS AG recalled Fosaprepitant for Injection 150 mg per vial in Jan 2024 — an FDA Class II recall (D-0262-2024) because Lack of Sterility Assurance: Aseptic process simulation failure.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Sterility Assurance: Aseptic process simulation failure.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 22,176 Vials
Details
- Product
- 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.
- Recalling company
- Be Pharms
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jan 10, 2024
- FDA report date
- Jan 31, 2024
Frequently asked
- Was Fosaprepitant for Injection 150 mg per vial recalled?
- BE PHARMACEUTICALS AG recalled Fosaprepitant for Injection 150 mg per vial in Jan 2024 — an FDA Class II recall (D-0262-2024) because Lack of Sterility Assurance: Aseptic process simulation failure. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Fosaprepitant for Injection 150 mg per vial recalled?
- Per the FDA enforcement record, the reason for recall D-0262-2024 was: Lack of Sterility Assurance: Aseptic process simulation failure.
- Is a recalled Fosaprepitant for Injection 150 mg per vial dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Fosaprepitant for Injection 150 mg per vial are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — lot #13D012AA, Exp: 08/31/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0262-2024.