According to reports, the US Food and Drug Administration (FDA) pointed out on Monday that Fresenius Kabi of the United States voluntarily recalled a nonsteroidal anti-inflammatory analgesic called Ketorolac Tromethamine. According to the agency, “particulates” characterized by oxygen, silicon, carbon and polyamide were found in eight sample bottles, and a total of 13 batches of injectable drugs were recalled. The recall statement stated that injection of this drug may cause serious, life-threatening complications.
According to the FDA, Ketorolac Tromethamine is a non-steroidal anti-inflammatory drug used to treat moderate to severe pain for up to 5 days. On April 20, Fresenius Kabi announced a voluntary recall of 13 batches of such injections, especially the drugs in 60mg / 2mL and 30mg / mL amber vials.
The company pointed out that the particles detected in the vial may cause various problems when injecting the drug, including the possibility of a fatal allergic reaction, as well as the formation of blood clots, irritation of blood vessels, swelling at the injection site, inflammation and infection of “tissue mass” Or blocked blood vessels.
Fresenius Kabi stated that both distributors and users of the drug will receive a letter of notification regarding the recall; these recalled vials should be stopped immediately. Fresenius Kabi stated that the company is accepting product returns. The company is also answering questions for customers who have questions about the recall. The FDA posted a complete list of vials recalled on its website, which can be seen here.
The FDA stated that anyone who is using the product should contact a doctor for evaluation if they encounter problems related to it. Both FDA and pharmaceutical companies are accepting consumer adverse event reports.