Levetiracetam Tablet, Film Coated
FDA Recall NDC 0378-5619
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Levetiracetam (NDC 0378-5619). A significant event, classified as Class II, was initiated on Jul 27, 2012 by Mylan Pharmaceuticals Inc.. The reported reason for this action was: "Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.
Jul 27, 2012
Oct 03, 2012
960 bottles
Recall Profile & Regulatory Data
Event ID
62885
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mylan Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
The product was distributed to KY.
Termination Date
May 21, 2013
Product Description
Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05
Batch or Lot Expiration Information
Lot# Lot ZLMM12063, Exp March 2014
Affected Packages Involved in this Recall
0378-5615-78Product
0378-5615-05Product
0378-5617-78Product
0378-5617-05Product
0378-5619-91Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
