← FDA ENFORCEMENT
D-0078-2025Class II

Aurobindo Pharma USA Inc

Recalling firm
Aurobindo Pharma USA Inc
Product type
Drug
Status
Ongoing
Report date
2024-12-11
Distribution
USA Nationwide
Firm state
NJ
Product quantity
3336 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

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.

Code / lot 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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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.