aurobindo pharma usa inc
3 recalls on record
A
Aurobindo Pharma USA Inc — 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
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
FDAHealth
A
Aurobindo Pharma USA Inc — 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 US
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
FDAHealth
A
Aurobindo Pharma USA Inc — 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 US
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
FDAHealth