The 29 lots of single and 51 lots of combination Valsartan medicines distributed under the Actavis label in the US are being recalled due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical.
During an assessment of improving the manufacturing process, Huahai found valsartan was tainted by a minute level of N-nitrosodimethylamine (NDMA), a genotoxic substance that could cause cancer, based on results from animal tests, according to another statement issued by the company on July 7. "The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured", the FDA said in a press release. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.
The authority, taking notice of misconception declares in clear terms that valsartan medicine made by Pakistani companies is not banned and only batches manufactured by the valsartan raw material manufactured using are being recalled.
The move comes after 22 other countries recalled the drug due to it containing a chemical that poses a potential cancer risk.
Huahai has said it is unable to determine how much it will lose from the recall, but its own data shows that sales of valsartan, which is mostly sold to North America, Europe, India, Russia and South America, totaled CNY328 million (USD49 million) past year, compared with total revenue of CNY5 billion (USD749 million).
Germany, Italy, Finland and Australia also recalled the medications that include Valsartan.
The FDA will continue to investigate this issue and provide additional information when it becomes available. In some patients, vulsartan is becoming life-saving medicine.
FDA is spending time in reviewing the drug and in the meantime, three companies which are based in the U.S. has refused to sell the medications which are containing valsartan.
This is the list of medications recalled by the FDA.
Scott Gottlieb said "The FDA is committed to maintaining our gold standard for safety and efficacy". This is raising concerns among the people about what medications can be used without causing further deterioration to the patients. According to Harry Lever, a cardiologist at the Cleveland Clinic, "It's not just valsartan".