FDA-Drug2024-12-11Class II
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.
Aurobindo Pharma USA Inc
Hazard
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Sold states
USA Nationwide
Affected count
3336 bottles
Manufactured in
279 Princeton Hightstown Rd, East Windsor, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0078-2025Don't want to check this manually?
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