Par Pharmaceutical, Inc. (Par) has initiated a voluntary recall of one lot of Treprostinil Injection 20mg/20mL (1mg/mL) due to potential silicone particulate contamination.
The recall, aimed at the consumer level, comes as a precautionary measure against possible adverse effects. Injecting products with particulate matter may cause local irritation or swelling and, if particles enter the bloodstream, they can lead to serious complications such as stroke or organ damage.
Although Par has not received any reports of adverse events linked to the affected lot (Lot 57014) thus far, the company is urging wholesale accounts and hospitals to cease use and distribution immediately. Par is coordinating the return of all inventory through Inmar, Inc., and advises those who have further distributed the recalled product to notify relevant accounts promptly.
For more details and information, visit: fda.gov.
Reporting for WGRT – Choze Powell
