A single lot of Treprostinil injection is being recalled by manufacturer Par Pharmaceutical Inc based on concerns about the potential for silicone particulates to be present in the product solution, according to a company press release. 

Treprostinil remains a widely used go-to treatment for pulmonary arterial hypertension, especially in North America, according to industry data.

Local irritation or swelling may occur in response to the particulate matter from an affected injectable treprostinil product. If particulates enter the blood vessels, they can travel to various organs and block blood flow to the heart, lungs, or brain and result in stroke and potentially death, according to the company.

However, the company has not received any reports of adverse events related to the recall as of the press release date of March 12, 2024.

Treprostinil is frequently used to improve symptoms associated with exercise in patients with PAH and to manage patients in need of transition from epoprostenol, according to the company.

The only lot affected by the current recall is Lot 57014, with an expiration date of 04/2024, according to the company. The product is packaged in 20 mL multidose vials as sterile solutions in water for injection, then packaged individually in cartons under NDC #42023-206-01. The recalled lot was distributed to wholesalers and hospitals across the United States from June 16, 2022, through October 17, 2022.

Be Aware, But Reassure

“Treprostinil has historically used to treat group I pulmonary arterial hypertension, and in recent years has been approved for use in group III PH-ILD, becoming the first approved Group III therapy,” said Corinne R. Young, MSN, FNP-C, FCCP, a nurse practitioner at Colorado Springs Pulmonary Consultants, in an interview. 

“Any time there are drug or device recalls, the first concern is our patients who depend on these therapies,” Young said. “Specifically, this class of drug is known to have significant withdrawal burden if suddenly stopped,” she said. 

Patients being treated with Treprostinil do have alternatives, Young noted. “Treprostinil is now available in IV [intravenous] infusion, SC [subcutaneous] injection, nebulized solution, DP [dry powder] inhaler, and in tablet form,” she said. “With only the liquid form being recalled, there are other options to which patients may can switch; however, coverage, tolerability, and dose equivalents vary and will create a complicated transition,” she added.

“I would reassure patients that only one lot was affected, distributed in 2022, with no reports of harm to patients thus far,” Young told Medscape Medical News. “These doses are set to expire in April 2024, after which the threat will be eliminated.”

Adverse events related to Treprostinil should be reported via online, mail, or fax to the FDA’s MedWatch Adverse Event Reporting program.

Young had no financial conflicts to disclose but serves on the Editorial Board of CHEST Physician.