D-0077-2025 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
- 102576 bottles
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.
Reason for Recall
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Distribution Pattern
USA Nationwide
Code Information
Lot #: a) CFSA23001A, CFSA23002A, CFSA23003A, Exp 03/31/2025; CFSA23004A, Exp 07/31/2025; CFSA23005A, Exp 10/31/2025; b) P2300191, P2300192, P2300193, P2300194, Exp 12/31/2024