India, March 13 -- 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...