October 2019 FDA Recall Drug by X-gen Pharmaceuticals Inc.
D-0519-2020 - Labeling
This Class III drug recall was voluntarily initiated by X-gen Pharmaceuticals Inc. on October 11, 2019 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0519-2020
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
10-11-2019
11-27-2019
25120 vials
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
X-Gen Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S.A. Nationwide
08-16-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
