The FDA alerting the public of a recall of several widely distributed Exela products after finding silicone during routine inspection of the products.
The products inlvuce an 8.4% Sodium Bicarbonate injection which is used to treat blood acidity levels,
Midazolam which is used for sedation and often packaged in a 100 milliliter glass vial, and ELCYS which is used for nutritional support, usually in new born babies and adults with liver failure.
The drug may cause local irritation or swelling in response to the silicone found within, the FDA also warns that if the silicone reaches blood vessels it can travel to various organs and even block the heart, lungs, and brain… this can lead to stroke or death.
These products were distributed as early as 2022 and as late as September 2023
