The FDA also issued a formal request to the compounding pharmacy to recall its products that are intended to be sterile. The drugs include hormone replacement products and injectable nutritional products like vitamins and amino acids.
All of this stems from an FDA inspection of Medaus’ facilities in March, during which the agency found unsanitary conditions. Following that inspection, the FDA asked the company in March to recall non-expired lots of those products, but Medaus refused to do so. The FDA also warned healthcare professionals not to use the products in April.
“Patient safety is our top priority and patients deserve drugs that are made under safe conditions,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “We are deeply concerned about the safety of the products made by Medaus and the risks associated with them.”
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