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Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
cGMP deviations
Lack of Assurance of Sterility
Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.
Potential for contamination with salmonella.
Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
The referred batch was produced without the laser engraving of 7 mm.
Maserati North America, Inc. (Maserati) is recalling certain 2024 Granturismo vehicles. The tire label may detach from the driver's side B-Pillar. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 110, "Tire Selection and Rims."
Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.
Oshkosh Corporation (Oshkosh) is recalling certain 2025 Defense NGDV ICE 2WD, AWD, and BEV 2WD vehicles. The rearview camera image may not display when the vehicle is placed in reverse. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 111, "Rear Visibility."
Prevost Car (US) Inc. (Prevost) is recalling certain 2025 Prevost H3-45 and X3-45 motorcoaches. The release mechanism on the emergency exit windows may be difficult to open in an emergency situation. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 217, "Bus Emergency Exits and Window Retention and Release."
Forest River, Inc. (Forest River) is recalling certain 2024-2025 Coachmen Catalina, Forest River Aurora, Cascade, Cedar Creek, Cherokee, Sandpiper, Sierra, 2025 Campsite Reserve, Impression, Pause, Puma, Sabre, Salem, Vengeance, and Wildwood fifth wheel and travel trailers, equipped with a removable step assembly. The clip-on bracket mounting bolts may come loose, allowing the steps to detach.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.