Fosaprepitant Injection (BE Pharmaceuticals) – Sterility Failure (2024)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
BE PHARMACEUTICALS AG
Lot Codes / Batch Numbers
lot #13D012AA, Exp: 08/31/2025
Products Sold
lot #13D012AA, Exp: 08/31/2025
BE PHARMACEUTICALS AG is recalling Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only aft due to Lack of Sterility Assurance: Aseptic process simulation failure.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Sterility Assurance: Aseptic process simulation failure.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026