America’s Unsafe Medical Products

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Possible Lack of Sterility in Ophthalmic Products Sold by Walgreens
> Issue date: July 3, 2019
> Type of alert: Recall

Altaire Pharmaceuticals is voluntarily recalling several ophthalmic products that may not be sterile sold over-the-counter at Walgreens pharmacies. According to the FDA, “Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death.” The list of recalled products is available at the FDA website.

Possible Lack of Sterility in Ophthalmic Products Sold Under Perrigo Brand
> Issue date: July 3, 2019
> Type of alert: Recall

Altaire Pharmaceuticals is voluntarily recalling several ophthalmic products sold to Perrigo that may not be sterile, which distributes them to its own customers. According to the FDA, “Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death.” The list of recalled products is available at the FDA website.

Chemotherapy Drug May Contain Glass Particulate
> Issue date: July 2, 2019
> Type of alert: Recall

Fresenius Kabi USA is voluntarily recalling two lots of its Fluorouracil intravenous chemotherapy drug used to treat a variety of cancers due to the potential for glass particulate. Using a product with glass particulate could be life-threatening.

Infusion Pump Syringe May Leak
> Issue date: July 1, 2019
> Type of alert: Recall

Becton Dickinson is recalling 2,900 SmartSite Syringe Administration sets that are used with an infusion pump to deliver fluids to patients. The sets may leak causing under‐infusion of critical medications, delay or interruption of infusions, contamination of the fluid paths and/or health care provider exposures to hazardous medications. This is a Class I recall, an FDA category for the most serious type of recall, indicating that the device “may cause serious injury or death.”

Device Used in Bypass Surgery May Rupture
> Issue date: July 1, 2019
> Type of alert: Recall

Edwards LifeSciences is recalling 727 IntraClude Intra-Aortic Occlusion devices due to the risk that the balloon used to block and vent the aorta during surgery may rupture causing serious adverse health consequences. This is a Class I recall, an FDA category for the most serious type of recall, indicating that the device “may cause serious injury or death.”

Also be sure to check out the medical safety alerts issued in the first half of 2019.

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