Banzel recall: CGMP Deviations
Banzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by Eisai Co., Ltd. Marketed by Eisai Inc. Woodcliff Lake, NJ…
Why was Banzel recalled?
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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?
80643
- Product
- Banzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by Eisai Co., Ltd. Marketed by Eisai Inc. Woodcliff Lake, NJ…
- Recalling firm
- Cardinal Health Inc.
- Quantity
- 30 bottles
- Distribution
- FL, GA, SC
- Recall date
- June 2, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)