FDAHealthNovember 7, 2024

Aurobindo Pharma USA Inc — 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 US

⚠️ cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: November 7, 2024

USA Nationwide

What's affected?

Product: 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.
Brand: Aurobindo Pharma USA Inc
Lot code: a)

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 102576 bottles.

View original FDA notice →

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