Aurobindo Pharma USA Inc. 2023-08-30 Health serious FDA
Health · FDA · Recall #FDA-D-1088-2023
Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: … Recall
Issued August 30, 2023 · Aurobindo Pharma USA Inc.
In August 2023, Aurobindo Pharma USA Inc. recalled the Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
cGMP deviations: Batch was released prior to approval.
What you should do
- 1 Stop using Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: … right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Aurobindo Pharma USA Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Aurobindo Pharma USA Inc.
- Category
- Health
- Recall date
- August 30, 2023
- Units affected
- Not reported
- Sold at
- USA nationwide
- Recall number
- FDA-D-1088-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Aurobindo Pharma USA Inc. has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.