Aurobindo Pharma’s wholly owned subsidiary -- Aurobindo Pharma USA Inc., is recalling over 1 lakh bottles of Cinacalcet tablets in multiple strengths in the US market. The New Jersey-based firm is recalling the product due to 'GMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit. The company initiated the Class II recall on November 7, 2024. Cinacalcet tablets are used to treat hyperparathyroidism.
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.
