Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use recall — FDA D-0262-2024
Lack of Sterility Assurance: Aseptic process simulation failure.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,685 detailed records are currently available in this category.
Lack of Sterility Assurance: Aseptic process simulation failure.
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Presence of Particulate Matter; identified as glass
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Chemical contamination: presence of benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Chemical contamination: presence of benzene
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Chemical contamination: presence of benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Chemical contamination: presence of benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Presence of Particulate Matter; identified as glass
Chemical Contamination: presence of benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Chemical contamination: presence of benzene
Presence of Particulate Matter; identified as glass
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