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cGMP Deviations
Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine.
Chemical Contamination: presence of benzene
Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.
Cummins, Inc. (Cummins) is recalling certain L9 Diesel Engines, with part number D563027BX03, that are equipped with a remote Stage 2 fuel filter and pressurized hoses. A fuel leak may occur from the fuel hose between the fuel pump and the remote fuel filter head.
Corp. Micro Bird, Inc. (Micro Bird) is recalling certain 2003-2015 MBII, 2015-2021 T-Series, and 2006-2022 G5 transit buses. The emergency release handle on the service door may bind, not allowing the door panels to open.
Summit Bodyworks is recalling one 2017 Freightliner M2-106 vehicle. The all-in-one rear LED lights may be too bright, exceeding the maximum light output allowed which may adversely affect the vision of drivers. As such, this vehicle fails to comply with the requirements of the Federal Motor Vehicle Safety Standard (FMVSS) number 108, "Lamps, Reflective Devices, and Associated Equipment."
Jayco, Inc. (Jayco) is recalling certain 2019-2021 Anthem, Aspire, Cornerstone, Insignia, Reatta, and Embark recreational vehicles equipped with Hehr 6400 series windows. The adhesive that bonds the vented portion of the window may fail.
Corp. Micro Bird, Inc. (Micro Bird) is recalling certain 2003-2022 MBII, T-Series, and G5 school buses. The emergency release handle on the service door may bind, not allowing the door panels to open.
A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to inflate.
Mercedes-Benz USA, LLC (MBUSA) is recalling certain 2020 GLB 250 vehicles. The accessory power outlet for the second-row seating may have excessive voltage due to an incorrect voltage converter socket.
Mercedes-Benz USA, LLC (MBUSA) is recalling certain 2021 CLS450, AMG E53, AMG CLS53, E350, E450, AMG GT43, AMG GT53, 2020 S450, S560, G550, AMG GLC63, 2020-2021 GLC300, and AMG G63 vehicles. The side crash sensor connectors may come loose, which could delay the activation of air bags and seatbelts during a side impact crash.