Guanfacine Extended-Release Tablets 2 mg,100-count bottles recall — FDA D-0324-2021
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
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Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled as Moisturizing Foam Hand Sanitizer
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Failed Moisture Limits: Out of specification for water content
Kia Motors America (Kia) is recalling certain 2020-2021 Soul, and 2021 Seltos vehicles equipped with 2.0L Nu MPI engines. The piston oil rings may not have been properly heat-treated, which…
General Motors, LLC (GM) is recalling certain 2010-2015, 2017 Buick Enclave, 2010-2019 Chevrolet Traverse, and 2011-2016 GMC Acadia vehicles. The side curtain air bags may not be properly…
A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an…
Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
Two lots of test strips failed QC testing using blank buffer due to false positives.
Their is a potential that the automated staining instrument with software version 3.5.3.1 may move with random speeds in random direction across its range of motion. This could result in…
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the…
Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and 4.2.7.3. Range/accuracy of heart rate meter for pediatric mode-In pediatric mode, when the input signal rate is over 300…
Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail…
The tube holder can separate from the barrier that secures the device to the patients' body. The tube holder has the potential failure to separate from the barrier. This separation might…
The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.
The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the…
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the…
An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues observed include the…
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the…
The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the…
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
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