X-Gen Pharmaceuticals Inc. recalls Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limit
Recalled November 27, 2019 · FDA recall D-0519-2020 · X-Gen Pharmaceuticals
Hazard
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached. · FDA Class III
Units
25120 vials
Sold at
U.S.A. Nationwide
Description
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
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
Manufacturer(s)
X-Gen Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →