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.Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. However, it is essential to talk with a physician before stopping the valsartan-containing medication and returning it.
The products are being recalled as a precautionary measure. This latest recall is further to recent recalls and other actions taken in Canada and internationally as a result of NDEA and another impurity, N-nitrosodimethylamine (NDMA), being found in certain drugs (see links below for related communications).
Mylan released a specific list of its recalled valsartan-containing products.
The recall took place because it was found that the products contained trace amounts of NDEA in the active pharmaceutical ingredient.This recall affects all non-expired products that were distributed between March 2017 and November 2018.
Media enquiries Public enquiries Update – November 28, 2018 .
HERTFORDSHIRE, England and PITTSBURGH, Nov. 20, 2018 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, … Normal business hours are Monday through Friday Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
According to the FDA, the risks associated with suddenly stopping the medication are more significant than the risks that exist from consuming trace amounts of NDEA.
The expiration dates of the medications range between 2018 and 2020.
Mylan’s stock took an even harder hit, dropping 3.4% once the expanded valsartan recall was announced. Drugs included in Mylan’s recall are: amlodipine and valsartan tablets; valsartan tablets Mylan Expands its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to All Lots Within Expiry Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical IngredientFor further information: Christine Waller (Media), 724.514.1968, or Melissa Trombetta (Investors), 724.514.1813 STEP 2: If your EpiPen ® Auto-Injector has been recalled, contact Stericycle at 877-650-3494 to obtain a voucher code for your free replacement product.
The following Mylan valsartan products are being recalled. Anyone who has experienced additional or worsening health problems after taking valsartan should see a physician and contact an attorney. Valsartan in combination with amlodipine or hydrochlorothiazide is used for the treatment of high blood pressure.
Consumers who develop serious problems after taking recalled valsartan products may be entitled to compensation for their Like!! Health Canada continues to work with companies and international regulatory partners to determine the scope and root cause of the issue, and to confirm that the necessary actions are taken to address it and prevent it from re-occurring. 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. Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan.
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Mylan released a specific list of its recalled valsartan-containing products.
Mylan initially recalled only a few lots from each category. Shortages are not anticipated as a result of this recall as there are alternative products available on the Canadian market. Consumers should check medication packaging for a lot number.
However, most of the affected bottles have 2019 expiration dates. Mylan continues to remain silent if prior, now expired lots of valsartan were also contaminated with cancer causing agents.
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