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All product recalls affecting California.
Includes nationwide recalls (tagged “Nationwide”) and recalls with California in the distribution area.
Undeclared Yellow #5 and Yellow #6.
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Some of the Vacuette CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
Subpotent drug
Triumph Motorcycles America, Ltd. (Triumph) is recalling certain 2024-2025 Daytona 660 motorcycles. The engine may fail due to internal damage from a disruption of oil flow.
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Chrysler (FCA US, LLC) is recalling certain 2026 Ram 3500, 3500 Cab Chassis, 2500, 4500 Cab Chassis, and 5500 Cab Chassis vehicles. The instrument panel may display an incorrect brake system warning light. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 101, "Control and Displays."
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Presence of Particulate Matter.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.