Mylan Laboratories Limited, (Nashik FDF) recalls
FDA enforcement reports naming Mylan Laboratories Limited, (Nashik FDF) as the recalling firm.
- Recall reports
- 13
- Class I (serious)
- 0
- Most recent report
- Dec 19, 2018
- Dec 19, 2018Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in Ind…Drug · Mylan Laboratories Limited, (Nashik FDF)GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.Class II
- Dec 19, 2018Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in Ind…Drug · Mylan Laboratories Limited, (Nashik FDF)GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.Class II
- Dec 19, 2018Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in Indi…Drug · Mylan Laboratories Limited, (Nashik FDF)GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.Class II
- Dec 19, 2018Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in Ind…Drug · Mylan Laboratories Limited, (Nashik FDF)GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.Class II
- Dec 19, 2018Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured fo…Drug · Mylan Laboratories Limited, (Nashik FDF)GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.Class II
- Dec 19, 2018Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured fo…Drug · Mylan Laboratories Limited, (Nashik FDF)GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.Class II
- Dec 19, 2018Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured f…Drug · Mylan Laboratories Limited, (Nashik FDF)GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.Class II
- Dec 19, 2018Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured f…Drug · Mylan Laboratories Limited, (Nashik FDF)GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.Class II
- Dec 19, 2018Valsartan and Hydrochlorothiazide Tablets, USP 80/12Drug · Mylan Laboratories Limited, (Nashik FDF)GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.Class II
- Dec 19, 2018Valsartan and Hydrochlorothiazide Tablets, USP 160/12Drug · Mylan Laboratories Limited, (Nashik FDF)GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.Class II
- Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378…
- Valsartan and Hydrochlorothiazide Tablets, USP 320/12
- Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378…
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