FDA-Drug2024-12-11Class II
Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 65862-833-30 90 mg - 500 Tablets - NDC 65862-833-05
Aurobindo Pharma USA Inc
Hazard
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Sold states
USA Nationwide
Manufactured in
279 Princeton Hightstown Rd, East Windsor, NJ, United States
Products
Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 65862-833-30 90 mg - 500 Tablets - NDC 65862-833-05
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0079-2025Don't want to check this manually?
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