Product: Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
Reason for recall: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Recall initiated: 20241107
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated