Dublin, Ireland -based Endo International plc announced that its operating company Par Pharmaceutical, Inc. is recalling one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level.
The recall, being conducted along with the U.S. Food and Drug Administration, is due to the potential for the presence of silicone particulates in the product solution.
The affected product is Treprostinil Injection 20mg/20mL (1mg/mL) with Lot code 57014 and expiration date 04/2024. The injection is distributed in 20mL multidose vials as sterile solutions in water for injection, individually packaged in cartons under NDC #42023-206-01.
The impacted lot was distributed nationwide to wholesalers and hospitals from June 16, 2022, through October 17, 2022.
Treprostinil Injection, a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension, is formulated for subcutaneous or intravenous infusion.
According to the company, administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If reaching the blood vessels, the particulate matter can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death.
However, Par has not received any reports of adverse events related to the recalled product to date.
Par is informing the wholesale accounts and the hospital location that have received the affected lot. It is also arranging for return of all existing inventory of Lot 57014 through Inmar, Inc.
Wholesale distributors and hospital pharmaciesare urged to immediately discontinue use of the product and stop distribution immediately.
In similar recalls, Hospira, Inc., owned by drug major Pfizer Inc., in October last year called back certain Sodium Bicarbonate and Lidocaine HCl Injections citing the potential for presence of glass particulate matter.
Merck Animal Health, affiliated to drug major Merck & Co., Inc., also recalled last year three batches of Banamine/Banamine-S (flunixin meglumine injection) 50 mg/mL in the United States citing the presence of particulate matter.
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