America’s Unsafe Drugs and Medical Products

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Heart Valve System Recalled
> Issue date: August 22, 2019
> Type of alert: Recall

Edwards Lifesciences is recalling 1,585 Sapien 3 Ultra delivery systems that are part of the company’s Sapien 3 Transcatheter Heart Valve System used to replace a diseased aortic valve without open-heart surgery. 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.” As of the end of July, Edwards had received reports of 17 injuries and one death related to the system.

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Migraine Medication May Be Contaminated
> Issue date: August 15, 2019
> Type of alert: Recall

Pfizer is voluntarily recalling two lots of its Relpax 40 mg tablets that may not meet the company’s in-house microbiological specification for the presence of two contaminants.

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Dangerous and Potentially Life-Threatening Side Effects of Miracle Mineral Solution
> Issue date: August 12, 2019
> Type of alert: Product warning

The FDA is warning consumers not to purchase or drink Miracle or Master Mineral Solution, Miracle Mineral Supplement, MMS, Chlorine Dioxide (CD) Protocol, Water Purification Solution (WPS) and other similar products. These products are promoted on social media as treatments for autism, cancer, HIV/AIDS, and other diseases but are not FDA-approved for any use.

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No Increase of Prostate Cancer to Patients Using Certain Medicines to Treat Parkinson’s Disease
> Issue date: August 13, 2019
> Type of alert: Safety communication

Following additional review, the FDA found no increased risk of prostate cancer in patients using Comtan and Stalevo, both of which contain entacapone, for treating Parkinson’s disease.

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Infusion Pump Recalled
> Issue date: August 12, 2019
> Type of alert: Recall

The Volumat MC Agilia Infusion System made by Fresenius Kabi is being recalled to change an alarm from low priority to high priority when the infusion is complete. The company is also making corrections to other issues in its software library. This is a Class I recall for 9,461 infusion pumps and 83 drug software libraries.