Class II · Moderate risk
Rufinamide Tablets 200mg
CGMP Deviations
Rufinamide Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations: Batch was released prior to approval.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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
Affected NDC
59651-0616-08
Compare with the code on your package — it is the most precise check available.
Drug: Rufinamide
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Rufinamide NDC 59651-0616 |
200 mg/1 | Tablet, Film Coated Oral |
Aurobindo Pharma Limited | Rx |
- Recalling firm
- Aurobindo Pharma USA Inc.
- NDC code
- 59651-616-08
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1087-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Rufinamide recalls
See all
Class II · Moderate risk
Rufinamide Tablets
cGMP deviations: Batch was released prior to approval.
Class II · Moderate risk
Banzel (rufinamide)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by Aurobindo Pharma USA Inc.
All 2023 recalls
Class II · Moderate risk
Dicyclomine Hydrochloride Capsules
shortfill; reports of empty capsules.
Class II · Moderate risk
Acetaminophen Tablets
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Class II · Moderate risk
Nebivolol Tablets
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Class II · Moderate risk
Cinacalcet Tablets
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
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