Valsartan was originally developed by Novartis and approved by the U.S. Food & Drug Administration (FDA) in 2003. It went off-patent in 2012, so the medicine is now used in dozens of other generic drugs.
Novartis said in a press release that a version of Valastran which contains valsartan/HCT film-coated tablets are being recalled because they “do not meet our high quality standards.” British pharmacies have been warned to recall valsartan-containing products made by Dexcel Pharma Ltd and Accord Healthcare, EMA said.
The recall affects approximately 2,300 batches that were distributed across the globe to Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain and Malta.
A Novartis spokesperson said that products distributed to the U.S. are not included in the recall. FDA spokeswoman Sandy Walsh said the agency is aware of the situation and “has no comment at this time,” adding that it is “committed to informing the public in a timely manner when the agency identifies safety issues. Generally, the agency does not comment on third-party announcements, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”
The issue was discovered during routine testing on valsartan’s active ingredient in formulations synthesized overseas, EMA said. The agency reviewed medicines from the supplier, Zhejiang Huahai Pharmaceuticals in Linhai, China. The agency said the impurity is “a result of a change in the manufacturing process.”