FDA voluntarily recalls several blood pressure and heart failure medications due to risk of cancer

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On July 13, 2018, several drugs used to treat high blood pressure and heart failure have been voluntarily recalled by the FDA due to the risk of cancer.

As stated on the FDA website regarding the recall, “The exposure to the impurity N-nitrosodimethylamine (NDMA) that was detected in the valsartan product line presents an unacceptable carcinogenic risk to the intended patient population. To date, Prinston Pharmaceutical Inc. has not received any reports of adverse events related to this recall.”

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According to the FDA, the following drugs are included in this voluntary recall:

Product NDC Code Lot Number Expiry Dates Distribution Date
VALSARTAN TABLETS 40MG 30CT 43547-367-03 All lots From Jul 18 to Jan 20 Oct 2015 – Jun 2018
VALSARTAN TABLETS 80MG 90CT 43547-368-09 All lots From Jul 18 to Jan 20 Oct 2015 – Jun 2018
VALSARTAN TABLETS 160MG 90CT 43547-369-09 All lots From Jul 18 to Jan 20 Oct 2015 – Jun 2018
VALSARTAN TABLETS 320MG 90CT 43547-370-09 All lots From Jul 18 to Jan 20 Oct 2015 – Jun 2018
VALSARTAN/HCTZ 80MG/12.5MG 90CT TABLETS 43547-311-09 All lots From Jul 18 to Jan 20 Jun 2016 – Jun 2018
VALSARTAN/HCTZ 160MG/12.5MG 90CT TABLETS 43547-312-09 All lots From Jul 18 to Jan 20 Jun 2016 – Jun 2018
VALSARTAN/HCTZ 160MG/25MG 90CT TABLETS 43547-313-09 All lots From Jul 18 to Jan 20 Jun 2016 – Jun 2018
VALSARTAN/HCTZ 320MG/12.5MG 90CT TABLETS 43547-314-09 All lots From Jul 18 to Jan 20 Jun 2016 – Jun 2018
VALSARTAN/HCTZ 320MG/25MG 90CT TABLETS 43547-315-09 All lots From Jul 18 to Jan 20 Jun 2016 – Jun 2018

 

The lot number and expiration date of the medicine can be found on the manufacturer’s unit on the package.

This is an example of the Manufacturer’s label as provided by the FDA.

“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

For a product return, individuals are advised to contact Solco Customer Service at 1-866-931-9829, Option 5, Monday through Friday from 9 AM to 5 PM. You can also email customer service at customerservice@solcohealthcare.com or send them a fax to 1-866-931-0709.

If you have experienced any quality problems associated with the use of this product, you can report it to FDA’s MedWatch Adverse Event Reporting Program by phone at 1-800-332-1088, online, regular mail or fax at 1-800-FDA-0178.


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