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Class I Recall for Clotting Injection
04/09/2020
The recall is for phytonadione injectable emulsion, 10 mg/mL, 1-mL ampule (NDC 43598-405-11), packaged in 25 x 1-mL single-dose ampules per carton (NDC 43598-405-16). More than 10,000 cartons from lots ACB902 and ACB903 (Exp. 3/21), ACB904 (Exp. 4/21), and ACB905 (Exp. 6/21) are included in the recall and were distributed within the United States.
Dr. Reddy's Laboratories voluntarily initiated the recall March 16, 2020. The FDA designated the recall Class I on April 6, 2020.
Phytonadione is a prescription vitamin K coagulant used to improve blood clotting factors impaired by medications or medical conditions.
—Jolynn Tumolo