Drug 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
D-0519-2020
Product summary
- Event
- Event 84027
- Status
- Terminated
- Classification
- Class III
- Quantity
- 25120 vials
- Official record key
drug-enforcement:D-0519-2020
Official wording
Reason: Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Code information: Lot #: 7603333, 7603334, 7603335, Exp 05/2020; 7051107, Exp 01/2022
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing