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BE PHARMACEUTICALS AG recalls Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution an

Recalled January 31, 2024 · FDA recall D-0262-2024 · BE PHARMACEUTICALS AG

Hazard
Lack of Sterility Assurance: Aseptic process simulation failure. · FDA Class II
Units
22,176 Vials
Sold at
Nationwide in the USA

Description

Lack of Sterility Assurance: Aseptic process simulation failure.

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.
Manufacturer(s)
BE PHARMACEUTICALS AG
Made in
Switzerland

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

BE PHARMACEUTICALS AG recalls Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution an | RecallWatchUSA