Keppra Tablet, Film Coated
FDA Recall NDC 50474-596
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 Keppra (NDC 50474-596). A significant event, classified as Class II, was initiated on Jul 18, 2019 by Ucb, Inc.. The reported reason for this action was: "Failed Dissolution Specifications."
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
Failed Dissolution Specifications.
Jul 18, 2019
Jul 31, 2019
2088 bottles
Recall Profile & Regulatory Data
Event ID
83368
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ucb, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
TN
Termination Date
Jan 24, 2020
Product Description
Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-597-66.
Batch or Lot Expiration Information
Lot# Lot: 908946 Exp. 02/2022
Affected Packages Involved in this Recall
50474-594-40Product
50474-595-40Product
50474-596-40Product
50474-597-66Product
50474-001-48Product
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.
