A week after two more blood pressure drugs were recalled because they have a possible cancer-causing ingredient, the U.S. based Mylan Pharmaceuticals expanded its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within dates of expiration.
Some of the batches aren't due to expire until August 2020.
--The 104 additional lots include 26 lots of Amlodipine and Valsartan tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths).
--Also: 51 lots of Valsartan tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochlorothiazide tablets, USP (80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg strengths).
"Out of an abundance of caution, these products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited," the Food and Drug Administration posted Tuesday.
According to the Food and Drug Administration, NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes. NDEA has been classified as a "probable human carcinogen" according to the International Agency for Research on Cancer.
The finished products are manufactured by Mylan Pharmaceuticals Inc. and Mylan Laboratories Limited. These batches were distributed domestically between March 2017 and November 2018.
The full list of expanded recalled batches can be viewed at https://www.fda.gov/Safety/Recalls/ucm627647.htm.
Late last month, Teva Pharmaceuticals pulled all lots of Amlodipine/Valsartan and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets for the same reason: too much NDEA in its Valsartan, the active ingredient made by Mylan India.
In November, Mylan also recalled 15 heart attack and blood pressure medications and Sandoz recalled Losartan blood pressure meds.
In July, five medications of Valsartan/Hyrdrochlorothiazide blood pressure drugs manufactured by Major Pharmaceuticals, Teva Pharmaceuticals and Solco Healthcare were recalled.
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According to the FDA, Valsartan is used for the treatment of high blood pressure and for the treatment of heart failure, and to reduce cardiovascular mortality following myocardial infarction.
Valsartan in combination with Amlodipine or Hydrochlorothiazide is used for the treatment of high blood pressure.
The recall suggests that patients who use these medications should contact their pharmacist or physician for advice on alternative treatment before returning their medication.
The recall warning made clear that patients who are on Valsartan should continue taking their medication "because the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment."
Mylan, the FDA said, is notifying its distributors and customers by letter and is arranging for the return of all recalled products.
The FDA suggested that consumers, including retailers, who have these recalled pills could contact Stericycle at 888-406-9305 for the return of the recalled product during business hours Monday through Friday.
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