Teva Pharmaceuticals USA IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for recall — FDA D-0765-2022
Presence of Particulate Matter: Product was found to contain silica and iron oxide
Complete FDA and NHTSA recall records dated in 2022, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Presence of Particulate Matter: Product was found to contain silica and iron oxide
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
BMW of North America, LLC (BMW) is recalling certain 2022 4 Series Gran Coupe (430i, 430i xDrive, M440i xDrive); 2019-2022 X5 sDrive40i, X5 xDrive40i, X5 xDrive50i, X5 M50i, X5M; 2021-2022…
Tesla, Inc. (Tesla) is recalling one 2022 Model X vehicle. A body structure reinforcement bracket was not installed at the second-row seat. As such, this vehicle fails to comply with the…
Tesla, Inc. (Tesla) is recalling certain 2018-2022 Model 3 Performance vehicles. The unit of speed (mph or km/h) may fail to display on the speedometer while in Track Mode. As such, these…
Chrysler (FCA US, LLC) is recalling certain 2022 Jeep Compass vehicles. The front seat head restraints were not welded properly. As such, these vehicles fail to comply with the requirements…
Nissan North America, Inc. (Nissan) is recalling certain 2022 Rogue vehicles. Due to a manufacturing error, an area on the bottom wall of the fuel tank may be too thin.
Ford Motor Company (Ford) is recalling certain 2020-2021 F-150, Expedition, 2020-2022 Super Duty F-250, F-350, F-450, F-550, and 2020-2021 Lincoln Navigator vehicles. The windshield wiper…
Ford Motor Company (Ford) is recalling certain 2022 F-150 vehicles. The power-adjustable telescoping steering column connector wiring may be too short. Wiring that is too short can become…
Ford Motor Company (Ford) is recalling certain 2019 F-150, Super Duty F-250, F-350, F-450, and F-550 vehicles. Due to a poor electrical connection, the rearview camera may intermittently…
This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the…
For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparative stage for the entire examination area prior to the exam. During acquisition of each…
It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in…
There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open or, if the locking pin is fully…
There is a potential for misquantitation high results of negative samples.
Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.
Cybersecurity Improvement Action-not equipped against potential cyber security threats
Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be…
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
There is potential for the images to be flipped left to right.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.