Reported Nov 27, 2019 · Terminated
Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private…
X-Gen Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: X-Gen Pharmaceuticals Inc. · 300 Daniel Zenker Dr · Horseheads, NY · 14845-1014
Is this the product you have?
- Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only
- Manufactured byAgile Specialties Private Limited Pilot No. 14, Sipcot II, Hosur-635 109 Tamil Nadu, India
- Manufactured forX-Gen Pharmaceuticals, Inc. Big Flats, NY 14814, NDC 39822-4000-1
- Lot codes and dates
Lot #: 760333376033347603335Exp 05/20207051107Exp 01/2022
- Amount recalled
- 25120 vials
Where it was sold
- Nationwide
Why it was recalled
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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