X-Gen Pharmaceuticals Inc. recalls Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limi…

Recall date

October 11, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0519-2020

FDA classification

Class III

Brand / firm

X-Gen Pharmaceuticals Inc.

Sold / distributed

U.S.A. Nationwide

Why it was recalled

Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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