Valsartan Recall Lawsuit

Valsartan Recall Lawsuit

Multiple manufacturers have voluntarily recalled their Valsartan medication after the FDA issued its largest ever class 1 recall due to N-Nitrosodimethylamine (NDMA) in supplies that were produced by Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP).  NDMA Is a known human carcinogen that can lead to serious health risks in high doses and through prolonged exposure.  The FDA first initiated a recall of Valsartan, both on its own and in combination with other pharmaceuticals, in July 2018 and have since expanded the recall to include additional manufacturers as of January 2019.  Major pharmaceutical companies and re-packagers that are impacted include:

·      Major Pharmaceuticals·      Bryant Ranch Prepack
·      Actavis·      H.J. Harkins Company
·      Teva Pharmaceuticals·      NuCare Pharmaceuticals
·      Solco Healthcare·      Proficient Rx
·      A-S Medication Solutions·      Lake Erie Medical (dba, Quality Care Products, LLC)
·      AvKARE
·      RemedyRepack

The FDA has provided a list of those recalls by manufacturer and lot number here. 

Valsartan is an angiotensin II receptor blocker (ARB) which keeps the blood vessels from narrowing and is primarily prescribed to treat hypertension (high blood pressure).  It can also be used to treat heart failure.  The FDA is warning that those who took contaminated Valsartan for at least one year between 2014 and 2018 could be at increased risk of cancer of the kidneys, liver, stomach or colorectal area.  A large number of pharmacies are reaching out directly to customers to let them know that they may have received a tainted lot of the prescriptions.  If you are currently taking Valsartan, speak with your doctors and pharmacist about potential exposure as not all of the prescriptions have contamination.  Also of note, batches of two other ARBs, Losartan and Irbesartan, have tested positive for carcinogens.  Potential symptoms to watch for with NDMA over-exposure include:

·      Liver damage·      Abdominal Cramps
·      Headache·      Enlarged Liver
·      Fever·      Dizziness
·      Vomiting·      Reduced function of: Kidney, liver and lungs
·      Jaundice

For additional information, please read more at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628189.htm

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