Recall: D-1088-2023

Class II - Potentially Harmful

Class IIClassification

2023-07-21Initiated

TerminatedStatus

Aurobindo Pharma USA Inc.Firm

Product

Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-617-08

Reason

cGMP deviations: Batch was released prior to approval.

Distribution

USA nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.