Apollo Care Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% recall — FDA D-0487-2023
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
Tesla, Inc. (Tesla) is recalling certain 2023 Model X vehicles equipped with a full self-driving computer 4.0 and running software release version 2023.2.200. Weak camera signal strength…
Tesla, Inc. (Tesla) is recalling certain 2018-2019 Model 3 vehicles. The front suspension lateral link fasteners may loosen, allowing the lateral link to separate from the sub-frame.
Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device installations or device replacement upgrades,…
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices…
There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive…
There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an…
There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an…
The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.
A software bug eliminated the initial ECG activation and review of the ECG under a physician. However, the device is only cleared for use under the care of a physician.
The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not to contact the outer shell to create a seal and thus, it does not create and…
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices…
There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an…
It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM…
There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an…
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices…
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices…
The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices…
Product is missing warning declaration that it contains phenylalanine.
The allergen of wheat was not declared on the label. (firm stated that soy was not declared as well, but upon review, soy was listed on the ingredient label)
The Butter Toffee, 16oz box, declares butter but does not declare milk. Label does not declare soy which is present in the non-stick spray being used on the Butter Toffee production trays.…
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