Par Pharmaceutical recalls Treprostinil Injection lot

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DUBLIN – Endo International (OTC:) plc’s subsidiary, Par Pharmaceutical, has initiated a voluntary recall of a specific lot of Treprostinil Injection, used for treating pulmonary arterial hypertension, due to potential contamination with silicone particulates. The affected lot, numbered 57014 with an expiration date of April 2024, was distributed to wholesalers and hospitals across the United States from June 16, 2022, to October 17, 2022.

The presence of silicone particulate matter in injectable products can be harmful. If administered, these particulates may cause local irritation or swelling, and if they enter the bloodstream, they have the potential to block blood vessels in vital organs, leading to serious health risks such as stroke or death. As of today, no adverse events related to this issue have been reported to Par.

Treprostinil Injection is a prostacyclin vasodilator designed for subcutaneous or intravenous infusion, prescribed to alleviate symptoms associated with exercise in patients with pulmonary arterial hypertension and to support patients transitioning from epoprostenol therapy.

Par is actively notifying wholesale accounts and hospitals that received the recalled lot and is arranging for the return of all inventory through Inmar, Inc. Wholesale distributors and hospital pharmacies in possession of the recalled product have been instructed to cease use and distribution immediately.

Healthcare providers are advised to contact their patients and instruct them to monitor for any issues that may arise from using this drug. Additionally, any adverse reactions or quality problems can be reported to the FDA’s MedWatch Adverse Event Reporting program.

The recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Endo International, the parent company, trades under the ticker OTC:ENDPQ and focuses on delivering quality, life-enhancing therapies.

This article is based on a press release statement from Endo International plc.

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