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Class I Recall for Clotting Injection


April 09, 2020

Dr. Reddy's Laboratories Inc. is recalling multiple lots of phytonadione injectable emulsion because ampules are breaking and shattering upon opening, according to the April 8, 2020, US Food and Drug Administration (FDA) Enforcement Report. The FDA designed the recall Class I, signaling use of the product could cause serious adverse health consequences or death. 

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

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