As a precaution, Cumberland Pharmaceuticals Inc. announced it will recall 6 lots of liver failure injection, Acetadote. The injections were initially approved to counteract overdoses of acetaminophen. The voluntary recall was enacted because some particulate matter was found in vials manufactured by an old supplier of Cumberland Pharma’s for the liver therapy injection. The company says the recall will have minimal impact on the drug’s supply.
Last month, the FDA refused to approve Acetadote due to insufficient data showing the prolonged survival of patients who suffer from acute liver failure. Acute liver failure is often deadly and liver transplantation is necessary. According to news reports, the FDA issued a complete response letter to state the reasons why they refused to approve the injection. The recall was voluntarily issued soon after the refusal to approve was issued by the FDA.
I hope no one is affected by the injection and it does not impact anyone’s health negatively. Impartial or incomplete evidence is a likely factor for a recall since it means the product has not been thoroughly tested or researched before releasing to the market. I understand why the FDA would be worried such a product would potentially lead to personal injury and other complications.