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The 19th Amendment was also known as the Susan B. Anthony Amendment during its passage – and for good reason. One of the leaders of the original suffragettes, Anthony co-founded and presided over the National American Woman Suffrage Association along with Elizabeth Cady Stanton. The goal of the group was […]

On July 2, 2020, MasterPharm, LLC, a compounding pharmacy based in South Richmond Hill, New York, announced the recall of various lots of numerous drugs compounded and distributed by the pharmacy.  The recall includes compounded formulations of: Calcium citrate tetrahydrate USP powder D-Biotin Estriol Finasteride Plus Formula 82F (combination of […]

In this fifth and final installment of our series on defective medical device issues, we are discussing the lack of a national device registry in the United States. Despite calls from various advocacy groups and some preliminary efforts at the federal level, the U.S. still lacks a central repository for […]

On May 12, 2020, MasterPharm, a compounding pharmacy based in New York, issued a recall of its popular hair regrowth formulation FinPlus. This medication, compounded by MasterPharm by prescription from a physician, includes finasteride 1.25 mg and a combination of Biotin, L-Lysine, Zinc, and riboflavin (vitamin B2) that are used […]

So far, our series discussing issues associated with defective implantable medical devices has focused on specific deficiencies in the U.S. Food and Drug Administration’s (FDA) approval and safety monitoring systems. First, we discussed the inherent conflicts of the 510k clearance process.  Then, we discussed the limited recall requirements for implantable […]

Issues with defective medical devices are so common that the U.S. Food and Drug Administration (FDA) has implemented a system designed specifically to identify and address medical device defects. This system, known as Medical Device Reporting (MDR), requires device manufacturers and importers to report known product defect or safety issues, […]

In Part Two of our series on defective medical device issues, we are talking about recalls. Implantable medical device recalls are common, and they can vary in terms of what they mean for patients. As the U.S. Food and Drug Administration (FDA) explains: “FDA uses the term ‘recall’ when a […]

Implantable medical devices offer invaluable benefits to individuals suffering from a broad range of ailments. They help people breathe, they help people walk and they provide an enhanced quality of life that simply is not available through other forms of medical treatment. Unfortunately, they can also be dangerous. Over the […]

Did you know that 32 million Americans have at least one medical device implant? As the main regulatory agency charged with ensuring the safety and efficacy of drugs and medical devices, the Food and Drug Administration (FDA) is entrusted with the safety and well-being of countless Americans every day. Their […]

Small particles of glass are to blame for the recall of a widely used fluticasone nasal spray that treats symptoms of hay fever in children. The nasal spray, known by its brand name Fluticasone Propionate Nasal Spray USP and manufactured by Apotex Corp., of Weston, Fla., was pulled voluntarily from […]