Febuxostat Tablets 40mg recall — FDA D-0368-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
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CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
cGMP Deviations: Products were stored outside the drug label specifications.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Failed Stability Specification: Water determination was found not complying with specification.
Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
cGMP Deviations: Products were stored outside the drug label specifications.
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Chrysler (FCA US, LLC) (Stellantis) is recalling certain 2021-2022 Ram ProMaster vehicles. The wiring harness may have a poor connection, which can cause the left taillight and left turn…
Chrysler (FCA US, LLC) (Stellantis) is recalling certain 2023-2024 Ram 1500, Jeep Wrangler, Jeep Wagoneer, Jeep Grand Wagoneer, Chrysler Pacifica, Ram 3500, Ram 3500 cab chassis, Ram 2500,…
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Ford Motor Company (Ford) is recalling certain 2024 Maverick vehicles. The fuel tanks may have an open pinch joint between the two molds, which can allow fuel to leak.
Ford Motor Company (Ford) is recalling certain 2023-2024 Bronco 4-door vehicles. The left-side rear door may be opened from the inside of the vehicle when the child safety lock is in the…
Ford Motor Company (Ford) is recalling certain 2022-2023 Bronco Sport and 2022 Escape vehicles equipped with 1.5L engines. A fuel injector may crack and leak fuel inside the engine…
Ford Motor Company (Ford) is recalling certain 2020 Explorer vehicles. Due to a poor electrical connection, the rearview camera may intermittently display a blank or distorted image. As…
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Subpotent Drug: Out of specification for assay
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Lack of Assurance of Sterility
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
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