Class II · Moderate risk Ongoing
Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh…
Reason CGMP Deviations
Is Rufinamide recalled?
4 FDA recalls mention Rufinamide. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Rufinamide.
Class II · Moderate risk Terminated
Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279…
Reason cGMP deviations: Batch was released prior to approval.
Class II · Moderate risk Terminated
Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279…
Reason cGMP deviations: Batch was released prior to approval.
Class II · Moderate risk Terminated
Banzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by Eisai Co., Ltd. Marketed by Eisai Inc…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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