FDAFDA · Food and drugs·Recall number D-0519-2020
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
Published November 27, 2019 · Recall initiated: October 11, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- X-Gen Pharmaceuticals Inc.
- Distributor
- U.S.A. Nationwide
- Lot
- Lot #: 7603333, 7603334, 7603335, Exp 05/2020; 7051107, Exp 01/2022
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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