TOPIC: One Lot of Treprostinil Injection by Par Pharmaceutical: Recall - Due to Potential for Silicone Particulates in the Product Solution
AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy
ISSUE: Par Pharmaceutical is recalling one lot 57014 of Treprostinil Injection 20 mg/20mL (1 mg/mL) due to the potential for the presence of silicone particulates in the product solution.
Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death.
The affected lot was distributed nationwide to wholesalers and hospitals from June 16, 2022, through October 17, 2022.
To date, Par Pharmaceutical has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: Treprostinil Injection is formulated for subcutaneous or intravenous infusion. The product is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension to diminish symptoms associated with exercise and for patients who require transition from epoprostenol to reduce the rate of clinical deterioration.
RECOMMENDATIONS:
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Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue use and stop distribution immediately.
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