D-0519-2020 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 27, 2019
- Initiation Date
- October 11, 2019
- Termination Date
- August 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25120 vials
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
Reason for Recall
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot #: 7603333, 7603334, 7603335, Exp 05/2020; 7051107, Exp 01/2022