FDA Drug Class III — Least Serious

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

Hazard

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

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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
Brand
X-Gen Pharmaceuticals Inc.
UPC
Lot #: 7603333, 7603334, 7603335, Exp 05/2020; 7051107, Exp 01/2022

Units Affected

25120 vials

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