D-0078-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- December 11, 2024
- Initiation Date
- November 7, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3336 bottles
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
Distribution Pattern
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