FDA-Drug2023-08-30Class II
Rufinamide Tablets, USP 200 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 59651-616-08
Aurobindo Pharma USA Inc.
Hazard
cGMP deviations: Batch was released prior to approval.
Sold states
USA nationwide
Affected count
48 bottles
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
Products
Rufinamide Tablets, USP 200 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 59651-616-08
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1087-2023Don't want to check this manually?
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