Treprostinil Injection 20mg

Endo International plc has announced that Par Pharmaceutical, Inc., one of its subsidiaries, is initiating a voluntary recall of a single lot of Treprostinil Injection, which has a concentration of 20mg/20mL (1mg/mL), at the consumer level. The recall of the product has been initiated because of the possibility that silicone particles may be present in the solution.

The administration of an injectable product containing particulate matter may result in local irritation or swelling due to the presence of foreign material. Should this particulate matter enter the bloodstream, it has the potential to travel to various organs and obstruct blood vessels in the heart, lungs, or brain, potentially causing a stroke or even death. To date, Par has not reported any adverse events associated with this recall."

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.

Treprostinil Injection 20mg/20mL (1mg/mL) is distributed in 20mL multidose vials as sterile solutions in water for injection, individually packaged in cartons under NDC #42023-206-01. Only Lot 57014, expiration date 04/2024 is affected by this recall. The lot was distributed nationwide to wholesalers and hospitals from June 16, 2022, through October 17, 2022.

Vials from the affected lot bear this label: [see above]

Par is issuing a written notice to wholesale accounts and hospital locations that have received the affected lot, coordinating the return of all current inventory of Lot 57014 through Inmar, Inc. Wholesale distributors and hospital pharmacies in possession of the recalled product should cease use and distribution immediately. Should you have further distributed the recalled product, please inform your accounts or any other locations that may have received it.

If consumers experience any issues potentially related to the consumption or use of this medication, they should reach out to their physician or healthcare provider.

Source: FDA