Drug Enforcement D-0078-2025

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

Status

Ongoing

Classification

Class II

Report Date

December 11, 2024

Termination Date

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Product Information

Product description
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.
Product quantity
3336 bottles
Reason for recall
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
Aurobindo Pharma USA Inc
Address
279 Princeton Hightstown Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0078-2025
Event ID
95730
Recall initiation date
November 7, 2024
Center classification date
November 29, 2024
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
More code info
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