FDA recall D-0243-2021

Bausch Health Companies, Inc. · Class III · drug

Product

Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05

Reason for recall

Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.

Distribution

Distributed Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2021-01-07
Report date: 2021-02-03
Termination date: 2022-02-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0243-2021