FDA recall D-0638-2021

Bausch Health Companies, Inc. · Class III · drug

Product

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

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide within the United States

Key facts

Status: Terminated
Initiation date: 2021-06-08
Report date: 2021-06-30
Termination date: 2023-02-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0638-2021