Levetiracetam Injection, Solution, Concentrate
FDA Recall NDC 39822-4000
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 39822-4000). A significant event, classified as Class III, was initiated on Oct 11, 2019 by Xgen Pharmaceuticals Djb, Inc.. The reported reason for this action was: "Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached."
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 III Terminated
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Oct 11, 2019
Nov 27, 2019
25120 vials
Recall Profile & Regulatory Data
Event ID
84027
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
X-Gen Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Aug 16, 2022
Product Description
Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Sipcot II, Hosur-635 109 Tamil Nadu, India, Manufactured for: X-Gen Pharmaceuticals, Inc. Big Flats, NY 14814, NDC 39822-4000-1
Batch or Lot Expiration Information
Lot# : 7603333, 7603334, 7603335, Exp 05/2020; 7051107, Exp 01/2022
Affected Packages Involved in this Recall
39822-4000-1Product
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.
