May 2021 FDA Recall Drug by Mckesson Corporation Dba Mckesson Drug Company
D-0630-2021 - Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. Product is labeled correctly as Levetiracetam

This Class III drug recall was voluntarily initiated by Mckesson Corporation Dba Mckesson Drug Company on May 26, 2021 for the product Drug. The FDA reported the reason for recall as labeling; wrong barcode; error in the machine-readable barcode which could result in some units being read as naproxen tablets 500 mg. product is labeled correctly as levetiracetam. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0630-2021

Reason for Recall
Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. Product is labeled correctly as Levetiracetam
Initiated
05-26-2021
Reported
06-16-2021
Quantity
210 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88008
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.
McKesson Corporation dba McKesson Drug Company
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.
Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2022
Product Description About Product Description
Full technical description of the product.
Levetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Distributed By: McKesson Corporation 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 090, India NDC 63739-795-10

Batch or Lot Expiration Information

Lot# Lot: 0000124916 Exp. 09/30/2022