Aurobindo Pharma USA Inc. is recalling Rufinamide Tablets (200 mg and 400 mg) because two batches were released for distribution before final manufacturing approval was obtained. The recall affects 48 bottles of the 200 mg strength and 48 bottles of the 400 mg strength, all packaged in 120-count bottles. No injuries or incidents have been reported to date, but the manufacturing process did not strictly follow required safety and quality approval steps.
The product was distributed without undergoing the final approval stage of the manufacturing process, meaning its quality and safety standards were not fully verified according to Good Manufacturing Practices (cGMP).
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Distributed by Aurobindo Pharma USA, Inc.
Distributed by Aurobindo Pharma USA, Inc.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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