Mylan Laboratories Limited, (Nashik FDF): Valsartan and Hydrochlorothiazide
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: 3084889 3084890 3093803. Return the recalled medication to the pharmacy where you purchased it for a full refund of the purchase price.
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