FDA recall D-0639-2021

Bausch Health Companies, Inc. · Class III · drug

Product

Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA, NDC 68682-170-30

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-0639-2021