Recalling firm
Aurobindo Pharma USA Inc.
Product type
Drug
Status
Terminated
Report date
2023-08-30
Distribution
USA nationwide
Firm state
NJ
Product quantity
48 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
cGMP deviations: Batch was released prior to approval.
Product description
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
Code / lot info
Lot #: RB4023002A, Exp 02/2025
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.