PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: June 23, 2021 Initiated: June 9, 2021 #D-0631-2021

Product Description

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.

Details

Recalling Firm
AVKARE Inc.
Units Affected
10 cartons
Distribution
Distributed in Los Angeles California
Location
Pulaski, TN

Frequently Asked Questions

What product was recalled?
Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13. Recalled by AVKARE Inc.. Units affected: 10 cartons.
Why was this product recalled?
Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 23, 2021. Severity: Low. Recall number: D-0631-2021.