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Recall Enforment Report D-1038-2019

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Aurobindo Pharma USA Inc., originally initiated on 12-31-2018 for the product Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90 The product was recalled due to gcmp deviations: fda analysis confirmed presence of trace amounts of an impurity, n-nitrosodiethylamine (ndea) found in the api used to manufacture the product.. The product was distributed in Product Was Distributed To Major Distribution Chains Throughout The United States. 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-1038-201912-31-201803-27-2019Class IIN/AValsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.Ongoing
D-1039-201912-31-201803-27-2019Class IIN/AValsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.Ongoing
D-1037-201912-31-201803-27-2019Class IIN/AValsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-570-30GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.Ongoing
D-1035-201912-31-201803-27-2019Class IIN/AValsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.Ongoing
D-1036-201912-31-201803-27-2019Class IIN/AAmlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
65862-570 ValsartanTablet, Film CoatedAurobindo Pharma LimitedDrug For Further Processing
65862-570Valsartan ValsartanTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-571 ValsartanTablet, Film CoatedAurobindo Pharma LimitedDrug For Further Processing
65862-571Valsartan ValsartanTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-572 ValsartanTablet, Film CoatedAurobindo Pharma LimitedDrug For Further Processing
65862-572Valsartan ValsartanTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-573 ValsartanTablet, Film CoatedAurobindo Pharma LimitedDrug For Further Processing
65862-573Valsartan ValsartanTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-737Amlodipine And Valsartan Amlodipine And ValsartanTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-738Amlodipine And Valsartan Amlodipine And ValsartanTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-739Amlodipine And Valsartan Amlodipine And ValsartanTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-740Amlodipine And Valsartan Amlodipine And ValsartanTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug