Reported Aug 30, 2023 · Terminated
Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279…
Aurobindo Pharma USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aurobindo Pharma USA Inc. · 279 Princeton Hightstown Rd · East Windsor, NJ · 08520-1401
Is this the product you have?
- Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only
- Distributed byAurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-616-08
- Lot codes and dates
Lot #: RB2023001AExp 02/2025
- Amount recalled
- 48 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
cGMP deviations: Batch was released prior to approval.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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