Par Pharmaceutical Issues Recall for Treprostinil Injection Due to Silicone Particulates

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Par Pharmaceutical Issues Recall for Treprostinil Injection Due to Silicone Particulates

Par Pharmaceutical, Inc. (Par), a subsidiary of Endo International plc based in Dublin, Ireland, has issued a voluntary nationwide recall on March 12, 2024, for one lot of Treprostinil Injection 20mg/20mL (1mg/mL). The recall is initiated due to the potential presence of silicone particulates in the product solution. This recall is pertinent to consumers, health professionals, and pharmacies.

Injectable products containing particulate matter pose risks such as local irritation or swelling at the injection site. Additionally, if the particulate matter enters the bloodstream, it can potentially travel to vital organs such as the heart, lungs, or brain, leading to severe consequences including stroke and death. As of now, Par has not received any adverse event reports related to this recall.

Treprostinil Injection is primarily used for subcutaneous or intravenous infusion and acts as a prostacyclin vasodilator. It is indicated for treating pulmonary arterial hypertension to alleviate symptoms associated with physical exertion and for patients transitioning from epoprostenol to mitigate clinical deterioration.

The affected product, Treprostinil Injection 20mg/20mL (1mg/mL), is distributed in 20mL multidose vials, packaged individually in cartons under NDC #42023-206-01. Only Lot 57014 with an expiration date of 04/2024 is subject to this recall. This lot was distributed nationwide to wholesalers and hospitals between June 16, 2022, and October 17, 2022.

Vials from Lot 57014 bear the following label:

Par is actively notifying wholesale accounts and hospital locations that received the affected lot, facilitating the return of all existing inventory of Lot 57014 through Inmar, Inc. Wholesale distributors and hospital pharmacies are urged to cease use and distribution immediately. Any further distribution of the recalled product should be reported to relevant accounts or additional locations that may have received it.

For information regarding the recall process, concerned parties can contact Inmar, Inc. at 1-855-410-3565 during business hours (Monday through Friday, 9 am to 5 pm EST). Medical or technical inquiries, product complaints, or reports of adverse events can be directed to 1-800-828-9393.

Consumers are advised to consult their physician or healthcare provider if they have encountered any issues potentially related to the use of this drug product. Adverse reactions or quality concerns associated with this product can be reported to the FDA’s MedWatch Adverse Event Reporting program online, via regular mail, or fax.

This recall is conducted in coordination with the U.S. Food and Drug Administration (FDA), ensuring regulatory oversight and compliance.