Class II

Drug Recall: 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-Hight

Aurobindo Pharma USA Inc · November 7, 2024

Reason for Recall

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Product Description

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.

Distribution

USA Nationwide

States Affected

NATIONWIDE

Quantity Affected

102576 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0077-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.