Recalls / Class III
Class IIID-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
- Affected lot / code info
- Lot #: 7603333, 7603334, 7603335, Exp 05/2020; 7051107, Exp 01/2022
Why it was recalled
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Recalling firm
- Firm
- X-Gen Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 300 Daniel Zenker Dr, N/A, Horseheads, New York 14845-1014
Distribution
- Quantity
- 25120 vials
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2019-10-11
- FDA classified
- 2019-11-21
- Posted by FDA
- 2019-11-27
- Terminated
- 2022-08-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0519-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.