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Recall Observatory FDA recall evidence

Drug 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

D-0630-2021

May 26, 2021

Class III

Product summary

Firm
McKesson Corporation dba McKesson Drug Company
Event
Event 88008
Status
Terminated
Classification
Class III
Quantity
210 cartons
Official record key
drug-enforcement:D-0630-2021

Official wording

Reason: 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

Code information: Lot: 0000124916 Exp. 09/30/2022

Distribution pattern: Nationwide in the US

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling; Wrong Barcode; error