Endo's Par Pharma issues recall of blood pressure med over possible contamination

A little more than a month after Par Pharmaceutical, a unit of Dublin's Endo International, yanked a batch of its Remodulin generics from U.S. shelves, the company is expanding its product pull. 

Par has issued a voluntary recall of seven lots of the injectable high blood pressure medication treprostinil due to the possible contamination of silicon particles in the solution.

Treprostinil for injection, which is approved for pulmonary arterial hypertension, is a generic to United Therapeutics’ Remodulin, which has been marketed for over 20 years.

The recall covers 20-milligram multidose vials as sterile solutions in water that were packaged in cartons with the designation NDC #42023-206-01, Endo said in an April 22 press release.

The drugs were distributed nationwide in the U.S. to wholesalers and hospitals between June 2022 and August 2023. The company added that it has notified the FDA of the recall.

The treprostinil lots in question were set to expire between April 2024 and March 2025, according to Endo's release. 

Treprostinil is typically used to reduce symptoms associated with exercise and for patients who require transition from epoprostenol to reduce the rate of clinical deterioration. 

The company said that it so far hasn’t received any reports of health or safety problems related to the recall.

The recall marks an expansion of the treprostinil pull Par initiated last month when it yanked a single batch of the drug over similar silicon particulate concerns. Taking an injectable drug tainted with particulates could result in irritation or swelling at the injection site, or even stroke or death if the particles reach the blood vessels and move to other organs, Par said at the time. 

As with the latest recall, Par said in March that it hadn't received any safety alerts tied to the suspect treprostinil batch.