Levetiracetam Injection recall: Labeling Error
Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Sipcot II…
Why was Levetiracetam Injection recalled?
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 7603333, 7603334, 7603335, Exp 05/2020; 7051107, Exp 01/2022
- 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…
- Recalling firm
- X-Gen Pharmaceuticals Inc.
- Quantity
- 25120 vials
- Distribution
- U.S.A. Nationwide
- Recall date
- November 27, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)