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Par Pharmaceutical has expanded its recall of Treprostinil Injection 20mg/20mL (1mg/mL) to include 7 lots due to the potential for silicone particulates in the product solution.
Treprostinil is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (WHO Group 1) to diminish symptoms associated with exercise; and for patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The treatment is administered by either subcutaneous or intravenous infusion.
The recall (NDC #42023-206-01) includes the following lots, which were distributed nationwide to wholesalers and hospitals between June 16, 2022 and August 7, 2023:
- Lot # 57014; Expiration date 4/2024
- Lot # 56911; Expiration date 4/2024
- Lot # 58528; Expiration date 5/2024
- Lot # 58529; Expiration date 5/2024
- Lot # 60064; Expiration date 7/2024
- Lot # 60075; Expiration date 7/2024
- Lot # 67939; Expiration date 3/2025
At this time, there have been no reports of adverse events associated with this recall. Administration of an injectable product that contains particulates can result in local adverse reactions (eg, irritation, swelling) and potentially serious systemic events (eg, stroke, death).
Adverse reactions and quality issues should be reported to the FDA’s MedWatch program.
References:
Par Pharmaceutical issues voluntary nationwide recall of seven lots of Treprostinil Injection due to potential for silicone particulates in the product solution. News release. Par Pharmaceutical. April 22, 2024. https://www.prnewswire.com/news-releases/par-pharmaceutical-issues-voluntary-nationwide-recall-of-seven-lots-of-treprostinil-injection-due-to-potential-for-silicone-particulates-in-the-product-solution-302123263.html.
