Tydemy recall — FDA D-1081-2023
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
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Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Subaru of America, Inc. (Subaru) is recalling certain 2024 Crosstrek and Impreza vehicles. Due to insufficient clearance, the instrument panel harness may contact the steering beam bracket,…
Hyundai Motor America (Hyundai) is recalling certain 2024 Tucson vehicles. The tire and loading information label may incorrectly indicate information about a spare tire. As such, these…
Ford Motor Company (Ford) is recalling certain 2023 Bronco vehicles. The transmission park system may have been damaged during assembly, which can prevent the parking pawl from fully…
Defective Delivery System
Lack of Assurance of Sterility
Lack of Assurance of Sterility
cGMP deviations: due to shipment of rejected units.
Kia America, Inc. (Kia) is recalling certain 2023 Soul, Sportage, and 2023-2024 Seltos vehicles. The electronic controller for the Idle Stop & Go oil pump assembly may contain damaged…
Hyundai Motor America (Hyundai) is recalling certain 2023-2024 Palisade Tucson, 2023 Sonata, Elantra, and Kona vehicles. The electronic controller for the Idle Stop & Go oil pump assembly…
Honda (American Honda Motor Co.) is recalling certain 2017, 2020, and 2022 CR-V vehicles. The certification label on the driver's side door states incorrect Gross Vehicle Weight Rating…
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Lack of Assurance of Sterility
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Lack of Assurance of Sterility
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
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