FDA Drug Recalls

Recalls / Class III

Class IIID-0630-2021

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

Affected lot / code info
Lot: 0000124916 Exp. 09/30/2022

Why it 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

Recalling firm

Firm
McKesson Corporation dba McKesson Drug Company
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
4853 Crumpler Rd, N/A, Memphis, Tennessee 38141-8301

Distribution

Quantity
210 cartons
Distribution pattern
Nationwide in the US

Timeline

Recall initiated
2021-05-26
FDA classified
2021-06-15
Posted by FDA
2021-06-16
Terminated
2022-09-29
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0630-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class III recall: drug · FDA Drug Recalls