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
Reported: August 30, 2023 Initiated: July 21, 2023 #D-1088-2023
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
Reason for Recall
cGMP deviations: Batch was released prior to approval.
Details
- Recalling Firm
- Aurobindo Pharma USA Inc.
- Units Affected
- 48 bottles
- Distribution
- USA nationwide
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Aurobindo Pharma USA Inc.. Units affected: 48 bottles.
Why was this product recalled? ▼
cGMP deviations: Batch was released prior to approval.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 30, 2023. Severity: Moderate. Recall number: D-1088-2023.
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