FDAClass IIIJune 23, 2021

Phytonadione Tablets 5 mg recall: Impurity Out of Spec

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

Why was Phytonadione Tablets 5 mg recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 38617 Exp. 10/2022

Product
Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13
Recalling firm
AVKARE Inc.
Quantity
10 cartons
Distribution
Distributed in Los Angeles California
Recall date
June 23, 2021
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls