Blood pressure medication sold nationwide have been recalled due to contamination of silicon particles. The affected products were distributed to wholesalers and hospitals nationwide between June 2022 and August 2023.
The FDA reported the recall, which was issued voluntarily by Par Pharmaceutical on April 22. Read on for more details, including exactly which medication the recall includes and what to do if you’ve used or purchased it.
Par Pharmaceutical Treprostinil Recall
According to the recall, seven lots of Treprostinil for injection, which is approved for pulmonary arterial hypertension, has been recalled due to the possible contamination of silicon particles in the solution. The following lots are included in the recall:
- Treprostinil Injection 20mg/20mL (1mg/mL); NDC: 42023-206-01; Lot #: 57014; Expiration date: 04/2024
- Treprostinil Injection 20mg/20mL (1mg/mL); NDC: 42023-206-01; Lot #: 56911; Expiration date: 04/2024
- Treprostinil Injection 20mg/20mL (1mg/mL); NDC: 42023-206-01; Lot #: 58528; Expiration date: 05/2024
- Treprostinil Injection 20mg/20mL (1mg/mL); NDC: 42023-206-01; Lot #: 58529; Expiration date: 05/2024
- Treprostinil Injection 20mg/20mL (1mg/mL); NDC: 42023-206-01; Lot #: 60064; Expiration date: 07/2024
- Treprostinil Injection 20mg/20mL (1mg/mL); NDC: 42023-206-01; Lot #: 60075; Expiration date: 07/2024
- Treprostinil Injection 20mg/20mL (1mg/mL); NDC: 42023-206-01; Lot #: 67939; Expiration date: 03/2025
According to a statement from Par Pharmaceutical, "Taking an injectable drug tainted with particulates could result in irritation or swelling at the injection site, or even stroke or death if the particles reach the blood vessels and move to other organs."
What To Do If You've Used Or Purchased The Recalled Product
Par Pharmaceutical has alerted all wholesale accounts and hospitals that have received the affected product, and are arranged for a return of all existing inventory through Inmar, Inc. Any hospitals and wholesalers should discontinue use and stop distribution immediately.
For more information about the recall process, you can call Inmar, Inc. at 1-855-410-3565 Monday through Friday between the hours of 9 am and 5 pm EST. For medical or technical product information or to report a product complaint or adverse event please call 1-800-828-9393.
Par Pharmaceutical has not received any reports of illness related to the recalled products, but if you are experiencing any adverse side affects after taking this medication, contact your healthcare provider immediately.
