Aurobindo Pharma USA Inc recalls Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-
Recalled December 11, 2024 · FDA recall D-0079-2025 · Aurobindo Pharma USA
Hazard
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit · FDA Class II
Sold at
USA Nationwide
Description
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Product
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
Manufacturer(s)
Aurobindo Pharma USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →