Levetiracetam Tablet, Film Coated
FDA Recall NDC 65862-246
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 65862-246). A significant event, classified as Class II, was initiated on Mar 18, 2020 by Aurobindo Pharma Limited. The reported reason for this action was: "CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed"
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
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Mar 18, 2020
Apr 22, 2020
8040 units
Recall Profile & Regulatory Data
Event ID
85183
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Mar 25, 2024
Product Description
Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08
Batch or Lot Expiration Information
Lot# : 24719001A1, Exp. Date 03/2021
Affected Packages Involved in this Recall
65862-245-08Product
65862-245-05Product
65862-246-08Product
65862-246-05Product
65862-247-08Product
65862-247-05Product
65862-315-30Product
65862-315-60Product
65862-315-05Product
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.
