Aurobindo Pharma USA Inc recalls Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-8
Recalled December 11, 2024 · FDA recall D-0078-2025 · Aurobindo Pharma USA
Hazard
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit · FDA Class II
Units
3336 bottles
Sold at
USA Nationwide
Description
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Product
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.
Manufacturer(s)
Aurobindo Pharma USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →