American Regent has issued a nationwide recall for one lot of its Papaverine Hydrochloride Injection USP, 60 mg/2 mL single dose vials, citing the presence of visible particulate matter identified as glass and/or paraformaldehyde.
The administration of injectable products containing such particulate matter poses serious health risks, including local irritation or swelling. More critically, the particles could obstruct blood vessels in vital organs like the heart, lungs, or brain, potentially leading to stroke or even death. Patients with pre-existing cardiovascular or pulmonary conditions face an elevated risk. To date, American Regent has not received any reports of adverse events linked to this specific recall.
Papaverine is a prescription medication used to relax smooth muscles and widen blood vessels, primarily for treating visceral spasms, poor blood circulation, and erectile dysfunction. It is administered intravenously under medical supervision. Consumers who have used this product should contact their physician or healthcare provider if they experience any related problems. Distributors, retailers, and healthcare facilities are advised to stop using and return or discard the recalled product. The FDA encourages reporting of adverse events to its MedWatch program.