Recall Enforment Report D-0312-2019

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Mylan Pharmaceuticals Inc., originally initiated on 11-20-2018 for the product Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1722-93. The product was recalled due to cgmp deviations: fda lab confirmed presence an impurity, n-nitrosodiethylamine (ndea) contained in the api used to manufacture the product.. The product was distributed in Product Was Distributed 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-0312-201911-20-201812-19-2018Class II12,336 bottlesAmlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1722-93.CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.Ongoing
D-0316-201911-20-201812-19-2018Class II25,147 bottlesValsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5815-77.CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.Ongoing
D-0315-201911-20-201812-19-2018Class II63,213 bottlesValsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5807-93.CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.Ongoing
D-0313-201911-20-201812-19-2018Class II24,709 bottlesValsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5813-77.CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.Ongoing
D-0314-201911-20-201812-19-2018Class II12,840 bottlesValsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5814-77.CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.Ongoing
D-0317-201911-20-201812-19-2018Class II5,660 bottlesValsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05.CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.Ongoing
D-0311-201911-20-201812-19-2018Class II23,478 bottlesAmlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1721-93.CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.Ongoing
D-0318-201911-20-201812-19-2018Class II48,302 bottlesAmlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1724-93.CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained 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
0378-1721Amlodipine And Valsartan Amlodipine And ValsartanTablet, Film CoatedOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-1722Amlodipine And Valsartan Amlodipine And ValsartanTablet, Film CoatedOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-1723Amlodipine And Valsartan Amlodipine And ValsartanTablet, Film CoatedOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-1724Amlodipine And Valsartan Amlodipine And ValsartanTablet, Film CoatedOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-5807Valsartan ValsartanTablet, Film CoatedOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-5813Valsartan ValsartanTablet, Film CoatedOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-5814Valsartan ValsartanTablet, Film CoatedOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-5815Valsartan ValsartanTablet, Film CoatedOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-6321Valsartan And Hydrochlorothiazide Valsartan And HydrochlorothiazideTablet, Film CoatedOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-6322Valsartan And Hydrochlorothiazide Valsartan And HydrochlorothiazideTablet, Film CoatedOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-6323Valsartan And Hydrochlorothiazide Valsartan And HydrochlorothiazideTablet, Film CoatedOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-6324Valsartan And Hydrochlorothiazide Valsartan And HydrochlorothiazideTablet, Film CoatedOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-6325Valsartan And Hydrochlorothiazide Valsartan And HydrochlorothiazideTablet, Film CoatedOralMylan Pharmaceuticals Inc.Human Prescription Drug