Recall D-0077-2025

US Class II Ongoing · initiated 2024-11-07

Recalling firm

Aurobindo Pharma USA Inc, NJ

Product

Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), 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

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