Class II
Ongoing
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.
- Company
- Aurobindo Pharma Usa Inc.
- Recall Initiated
- November 7, 2024
- Posted
- December 11, 2024
- Recall Number
- D-0078-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3336 bottles
- Firm Location
- East Windsor, NJ, United States
Reason for Recall
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Distribution
USA Nationwide
Lot / Code Info
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
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