FDA warns – Single lot of Treprostinil Injection recalled by Par Pharmaceutical due to potential trace of foreign matter

Par Pharmaceutical, Inc. (Par), one of the operating companies of Endo International, announced has recalled one lot of its 20 mg/20mL (1mg/mL) Treprostinil Injection because the product solution may contain silicone particulates, according to the FDA.

Officials warn that administering an injectable product with foreign matter can lead to localized irritation or swelling. In the event that particulate matter enters the blood stream, it may travel to a number of organs and constrict blood vessels “in the heart, lungs or brain,” which could then trigger a stroke and possibly result in death.

At the time of the FDA communication, Par has not been made aware of any adverse events connected to the recall.

Designed for “subcutaneous or intravenous infusion,” Treprostinil Injection is a prostacyclin vasodilator, which is used to treat pulmonary arterial hypertension in an effort to both manage symptoms linked with exercise and to help facilitate a patient’s transition from epoprostenol to decrease the rate of “clinical deterioration.”

The consumer-level recall, announced by the Dublin, Ireland-based company on March 12, 2024, covers Treprostinil Injection in 20mg/mL (1mg/mL) that was distributed across the U.S. to wholesale partners and hospitals between June 16, 2022, and October 17, 2022. The products come in 20mL multi-dose vials labeled as sterile solutions in water indicated for injection. Affected product solutions come individually packaged in cartons under NDC #42023-206-01. Consumers should note that only products bearing Lot # 57014 and expiration date “04/2024” are covered by the recall.

Since the announcement, Par has worked to notify via its wholesale partners and the hospital recipient of the affected lot, and a return program has been established via Inmar, Inc. to have all exiting products under Lot 57014 returned. All wholesale distributors and hospital pharmacies alike should immediately cease use of all affected products in their respective inventory. If an affected product has been further sub-distributed, all impacted accounts or locations should be notified of the recall.

Inmar, Inc. may be reached by the number provided in the FDA announcement during the given time window.

Anyone who has experienced problems related to use of the product should consult with their physician or healthcare provider.

As the FDA continues to monitor the recall, the agency asks that any related adverse reactions or quality issues be reported to its MedWatch program.


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