Another manufacturer of valsartan announced on Dec. 31 that it was recalling some tablets due to a detection of a carcinogenic substance.
Aurobindo Pharma USA said that the recall concerned 80 lots of various valsartan tablets.
In the Dec. 31, 2018, alert, the company said on the website of the Food and Drug Administration (FDA) that the recall was due to the detection of trace amounts “of an unexpected impurity” detected in the drug.
“The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer classification,” the company stated.
Aurobindo said it hasn’t received any reports from consumers related to the recalled products.
The valsartan tablets are used to control high blood pressure and treat heart failure.
The company claimed that patients who were prescribed the tablets should keep taking them, “as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.”
Patients should talk to their pharmacist or doctor for advice on alternative treatment.
A list of products and labels can be seen on the FDA’s website.
The valsartan pills distributed via Aurobindo Pharma USA, Inc. were sold under the Amlodipine brand name. The company said it was writing and calling customers and distributors regarding the recall and telling them to immediately stop distributing the lots in question.
The company was also working on obtaining all the recalled products.
Any questions regarding the return of the drug should contact Inmar\CLS-Medturn at 1-877-208-2407 or via email at [email protected].
More than a week ago, Torrent Pharmaceuticals Limited said it is voluntarily recalling two lots of Losartan potassium tablets, used to treat high blood pressure (hypertension), after traces of N-nitrosodiethylamine NDEA were discovered.
Including that recall, tablets manufactured by four companies have now been found to contain NDEA, including Aurobindo Pharma, Prinston Pharmaceutical, Hetero Labs, and Teva Pharmaceuticals. Apart from some of the Aurobindo tablets, all the tablets were in 320 mg packages.
Warning to Chinese Company
Meanwhile, in December, the FDA issued a warning for Chinese drug manufacturer Zhejiang Huahai Pharmaceutical Co. Ltd. for “several manufacturing violations at ZHP’s Chuannan facility, including impurity control, change control, and cross-contamination from one manufacturing process line to another.”
Zhejiang Huahai Pharmaceutical was also placed “on import alert” by the FDA earlier this year due to impurities in valsartan, another blood pressure medication.
The valsartan recall was first initiated in July after N-Nitrosodimethylamine (NDMA) was discovered in the drug. NDMA is also a known carcinogen.
Other investigations triggered recalls of other valsartan-containing drugs along with irbesartan- and losartan-containing products, the FDA said.
