FDA recall D-1087-2023

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

Reason for recall

cGMP deviations: Batch was released prior to approval.

Distribution

USA nationwide

Key facts

Status

Terminated

Initiation date

2023-07-21

Report date

2023-08-30

Termination date

2024-02-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1087-2023