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CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Lack of Assurance of Sterility
Jayco, Inc. (Jayco) is recalling certain 2024 Entegra Condor, Jayco Granite Ridge, 2025 Jayco Alante SE, Redhawk SE, and Entegra Odyssey SE motorhomes. The Occupant and Cargo Carrying Capacity (OCCC) on the Federal label may be incorrect and allow the vehicle to be overloaded. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 120, "Wheels and Rims - other than passenger cars."