FDA recall record

McKesson Corporation dba McKesson Drug Company Levetiracetam Tablets USP, 250 mg UD 100 recall — FDA 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…

Class IIIclassification
D-0630-2021official record ID
Jun 16, 2021report date

Recall record at a glance

Official recordD-0630-2021
CategoryDrug Recalls
ClassificationClass III
FDA record statusTerminated
Recalling firmMcKesson Corporation dba McKesson Drug Company
Report dateJun 16, 2021
Recall initiation dateMay 26, 2021
Quantity210 cartons
LocationMemphis, TN, United States

Official product description

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

Why the product was recalled

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

Distribution information

Nationwide in the US

How to read the classification

FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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