FDA recall D-0631-2021

AVKARE Inc. · Class III · drug

Product

Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13

Reason for recall

Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.

Distribution

Distributed in Los Angeles California

Key facts

Status
Terminated
Initiation date
2021-06-09
Report date
2021-06-23
Termination date
2023-06-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0631-2021