Endo’s Par Pharmaceutical is yanking one lot of its treprostinil injection from the U.S. market over concerns that silicone particles could be in vials of the drug.
The batch of the pulmonary arterial hypertension (PAH) drug expires next month and has been on the shelves since 2022 after it was distributed to wholesalers and hospitals from June to October of that year, the company said in a press release.
While Par has not yet received any reports of adverse events stemming from use of the recalled med, the consequences of particulate matter in an injectable could be dire. The impacts could range from irritation or swelling at the injection site to a stroke or even death if the particles reach the blood vessels and move to other organs.
The affected lot should immediately be discontinued from administration and distribution, Par said.
The company is issuing written notifications to customers who received the batch plus sorting out the return of the existing inventory.
Treprostinil for injection is a generic to United Therapeutics’ Remodulin, which has been marketed for over 20 years.
The drug, a prostacyclin vasodilator, is approved to reduce symptoms of PAH when used with exercise; it's also approved for patients who need to transition from tried and true PAH med epoprostenol. Remodulin is formulated for subcutaneous or intravenous infusion.
Meanwhile, it’s already been a busy month for U.S. drug recalls. A few days ago, the FDA disclosed a recall of more than 55,000 bottles of Sun Pharma's gout treatment febuxostat.
As for Par, its parent company Endo recently agreed to pay a bankruptcy settlement worth up to $464.9 million to the federal government after a Department of Justice investigation into its previous marketing of opioid painkiller Opana ER.