Aurobindo Pharma USA Inc. recalls Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279
Recalled August 30, 2023 · FDA recall D-1087-2023 · Aurobindo Pharma USA
Hazard
cGMP deviations: Batch was released prior to approval. · FDA Class II
Units
48 bottles
Sold at
USA nationwide
Description
cGMP deviations: Batch was released prior to approval.
Product
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
Manufacturer(s)
Aurobindo Pharma USA Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →