Drug product
Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 65862-833-30 90 mg - 500 Tablets - NDC 65862-833-05
D-0079-2025
Product summary
- Event
- Event 95730
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0079-2025
Official wording
Reason: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Code information: Lot #: a) CFSC23001A, CFSC23001B, Exp 03/31/2025; b) P2300195, Exp 12/31/2024
Distribution pattern: USA Nationwide
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso Cinacalcet impurity
-
Manufacturing or process control
cGMP Deviations