Aurobindo Pharma’s US-based arm is recalling 48 bottles of Rufinamide Tablets, (200 mg, packaged in 120-count bottle), due to cGMP (current good manufacturing practice) deviations. The batch was released prior to approval. Aurobindo Pharma USA Inc is also recalling 48 bottles of the same medication in different strengths (USP 400 mg) for similar reasons. The company initiated the Class II nationwide (US) recall on July 21 this year. Rufinamide tablets are used to treat seizure disorders.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
