February 05, 2021
Bausch Health Companies Inc. is voluntarily recalling phytonadione tablets manufactured for Valeant Pharmaceuticals and Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals, because samples tested out of specification for an impurity. The recall was included in the February 3, 2021, US Food and Drug Administration (FDA) Enforcement Report.
The recall includes the following products, which were distributed throughout the United States:
- 5-mg Mephyton (phytonadione) tablets, manufactured for Valeant Pharmaceuticals, in 100-count bottles (NDC 0187-1704-05) from lot 18L092P (Exp. 5/21); and
- 5-mg phytonadione tablets, manufactured for Oceanside Pharmaceuticals, in 30-count bottles (NDC 68682-170-30) from lot 18L091P (Exp. 5/21).
Bausch Health Companies initiated the recall January 7, 2021. The FDA designated the recall Class III on January 25, 2021, suggesting use of the recalled tablets is not likely to cause harm.
Phytonadione is prescription vitamin K used to treat people with blood clotting disorders or too little vitamin K.