Valsartan Product Recall Updated by FDA and Brunei

The US Food and Drug Administration (FDA) published updated lists of products included in the recall and the list of products not included in the valsartan recall.

Valsartan is an ingredient used to treat high blood pressure and heart failure. Certain products are being recalled due to an impurity.

The FDA first announced on July 13th the recall of non-expired products that contain the ingredient valsartan, supplied by Zhejiang Huahai Pharmaceuticals, Linhai, China.

On August 2nd, the FDA revised information related to A-S Medication on the list of products included in the recall.

The agency will continue to provide information when it becomes available.

FDA is working with drug manufacturers to ensure future valsartan active pharmaceutical ingredients (APIs) are not at risk of N-nitrosodimethylamine (NDMA) in the formation.

NDMA is classified as a probable human cancer-causing substance.

The FDA reminds manufacturers to thoroughly evaluate their API manufacturing processes, and changes to those processes, to detect any unsafe impurities. If a manufacturer detects new or higher levels of impurity, they should take action to prevent changes to the product’s safety profile.

Additionally, the FDA continues to remind consumers to take your current medicine until your doctor or pharmacist gives you a replacement or a different treatment option.

Jeremy H. Ashley, PharmD, Clinical Pharmacist, Brookshire Grocery Pharmacy Corporate Development said, “Affected patients are encouraged to consult their physician regarding alternative hypertension treatment before stopping the medication.”

Consumers and healthcare professionals should report any adverse reactions with valsartan-containing products, to the FDA’s MedWatch program to help the agency better understand the scope of the problem.

Separately, on August 4th, the Brunei Ministry of Health issued a press release stating it would like to reassure members of the public with regards to the quality of the Valsartan-containing medicines in Brunei Darussalam.

The Department of Pharmaceutical Services, Brunei Ministry of Health have identified 18 registered pharmaceutical products in Brunei Darussalam containing Valsartan as the active substance.

The registered brands identified on this page are not affected as the Valsartan is sourced from unaffected manufacturers.