FDAFDA · Food and drugs·Recall number D-0078-2025
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.
Published December 11, 2024 · Recall initiated: November 7, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aurobindo Pharma USA Inc
- Distributor
- USA Nationwide
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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