FDA recall D-0244-2021

Product

Phytonadione Tablets 5mg, 30-count bottle, 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: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-0244-2021