FDA recall D-0519-2020

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

Reason for recall

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

Distribution

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2019-10-11

Report date

2019-11-27

Termination date

2022-08-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horseheads, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0519-2020