June 2021 FDA Recall Drug by Avkare Inc.
D-0631-2021 - Failed Impurities Specification

This Class III drug recall was voluntarily initiated by Avkare Inc. on June 9, 2021 for the product Drug. The FDA reported the reason for recall as failed impurities specification. The product was distributed in Distributed in Los Angeles California and the recall is currently terminated.

Recall Number: D-0631-2021

Reason for Recall
Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Initiated
06-09-2021
Reported
06-23-2021
Quantity
10 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88091
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AVKARE Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in Los Angeles California
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-02-2023
Product Description About Product Description
Full technical description of the product.
Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13

Batch or Lot Expiration Information

Lot# Lot: 38617 Exp. 10/2022