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Recall Enforment Report D-0078-2025

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Aurobindo Pharma USA Inc, originally initiated on 11-07-2024 for the 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. The product was recalled due to cgmp deviations: presence of n-nitroso cinacalcet impurity above fda recommended interim limit. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0078-202511-07-202412-11-2024Class II3336 bottlesCinacalcet 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.cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limitOngoing
D-0079-202511-07-202412-11-2024Class IICinacalcet 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 65862-833-05cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limitOngoing
D-0077-202511-07-202412-11-2024Class II102576 bottlesCinacalcet 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 USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limitOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
65862-831Cinacalcet CinacalcetTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-832Cinacalcet CinacalcetTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-833Cinacalcet CinacalcetTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug