FDA Drug recall D-0519-2020
Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Si…
- FDA Drug
- Class III
- terminated
- Published 2019-11-27
On 2019-11-27 the FDA classified a Class III recall of Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Si… by X Gen Pharmaceuticals, citing labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0519-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-10-11 |
| Published | 2019-11-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | X Gen Pharmaceuticals |
| Distribution | US |
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
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Identifiers
| ndc | 39822-4000-1 |
|---|---|
| code_info | Lot #: 7603333, 7603334, 7603335, Exp 05/2020; 7051107, Exp 01/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0519-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.