Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count H...
FDA Recall #D-0078-2025 — Class II — November 7, 2024
Product Description
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
Recalling Firm
Aurobindo Pharma USA Inc — East Windsor, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3336 bottles
Distribution
USA Nationwide
Code Information
Lot #: a) CFSB23001A, Exp 03/31/2025, CFSB23002A, Exp 07/31/2025; CFSB23003A, Exp 10/31/2025; CFSB23004A, Exp 10/31/2025; b) P2300196, 12/31/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated