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Mylan recalls high blood pressure meds

The products contain trace amounts of an impurity

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Photo source: FDA
Mylan Pharmaceuticals is recalling select lots of Valsartan-containing products, used in the treatment of high bloodpressure.

The products contain trace amounts of an impurity, N-nitrosodiethylamine, which has been classified as a probable human carcinogen.

The following batches of products, distributed in the U.S. between March 2017, and November 2018, are being recalled:

NDCProduct DescriptionStrengthSizeLot NumberExpiry
0378-1721-93Amlodipine and Valsartan Tablets, USP5mg / 160mg3030660513/19
0378-1722-93Amlodipine and Valsartan Tablets, USP10mg / 160mg3030795001/20
0378-1724-93Amlodipine and Valsartan Tablets, USP10mg / 320mg30306198611/18
0378-1724-93Amlodipine and Valsartan Tablets, USP10mg / 320mg3030797091/20
0378-1724-93Amlodipine and Valsartan Tablets, USP10mg / 320mg30307761811/19
0378-1724-93Amlodipine and Valsartan Tablets, USP10mg / 320mg3030797081/20
0378-5813-77Valsartan Tablets, USP80mg9030637821/19
0378-5814-77Valsartan Tablets, USP160mg9030713527/19
0378-5807-93Valsartan Tablets, USP40mg30306116911/18
0378-5815-77Valsartan Tablets, USP320mg9030814993/20
0378-5815-77Valsartan Tablets, USP320mg9030800092/20
0378-5815-77Valsartan Tablets, USP320mg9030800102/20
0378-5815-77Valsartan Tablets, USP320mg9030792051/20
0378-6325-05Valsartan and Hydro chlorothiazide Tablets, USP320mg / 25mg50030848862/19
0378-6325-05Valsartan and Hydro chlorothiazide Tablets, USP320mg / 25mg500309380412/19

What to do

Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.

Consumers in possession of recalled product should contact Stericycle at (888) 406-9305 Monday through Friday 8 a.m. – 5 p.m. (EST) for the return of the recalled product.

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