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Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski...

FDA Recall #D-0631-2021 — Class III — June 9, 2021

Recall #D-0631-2021 Date: June 9, 2021 Classification: Class III Status: Terminated

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.

Recalling Firm

AVKARE Inc. — Pulaski, TN

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

10 cartons

Distribution

Distributed in Los Angeles California

Code Information

Lot: 38617 Exp. 10/2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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