Mylan Laboratories Limited, (Nashik FDF): Amlodipine and Valsartan Tablets, USP
Recall reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.. Recalled by Mylan Laboratories Limited, (Nashik FDF). Distribution: Product was distributed throughout the United States to several major distributors, including Puerto Rico.. Classification (Class II — potential health risk). Affected lots/NDC/dates: Lot Numbers: 3064086, 3066061, 3066062,3073145,3073146,3073147, 3076091, 3077619, 3082432. Return the recalled medication to the pharmacy where you purchased it for a full refund of the purchase price.
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