FDA-Drug2019-11-27Class III
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
X-Gen Pharmaceuticals Inc.
Hazard
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Sold states
U.S.A. Nationwide
Affected count
25120 vials
Manufactured in
300 Daniel Zenker Dr, N/A, Horseheads, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0519-2020Don't want to check this manually?
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