Recalling firm
Aurobindo Pharma USA Inc
Product type
Drug
Status
Ongoing
Report date
2024-12-11
Distribution
USA Nationwide
Firm state
NJ
Product quantity
102576 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Product description
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.
Code / lot info
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
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →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.