Second Firm Recalls Over 37,000 Bottles of Blood Clotting Drug

Bausch Health Companies Inc is recalling 37,797 bottles of phytonadione tablets because they failed to meet impurities/degradation specifications, according to the June 30, 2021, US Food and Drug Administration (FDA) Enforcement Report. The recall follows a similar recall by AvKare Inc included in the June 23, 2021, FDA Enforcement Report.

The Bausch Health Companies recall affects 5-mg phytonadione tablets in 30-count bottles (NDC 68682-170-30) from lots 19D013P (Exp. 7/21) and 20D099P (Exp. 10/22). The tablets were manufactured for Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North American, Bridgewater, NJ, and distributed within the United States.

Bausch Health Companies voluntarily initiated the recall June 8, 2021. The FDA designated the recall Class III on June 23, 2021. Under the recall classification, use of the affected tablets is not likely to cause harm.

Phytonadione is a prescription vitamin used to prevent bleeding in people with blood clotting problems or vitamin K deficiency.