Aurobindo Pharma USA has added valsartan tablets to its recall of contaminated heart and blood pressure drugs.
In October, Aurobindo recalled 22 lots of irbesartan Active Pharmaceutical Ingredient (API) because it was found to contain an impurity called N-nitrosodiethylamine (NDEA).
NDEA is classified as a probable human carcinogen.
Aurobindo’s recalled API was supplied to ScieGen Pharmaceuticals Inc., which manufactured finished irbesartan for sale in the United States.
On New Year’s Eve, Aurobindo announced it was recalling 80 lots of its Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets USP, and Valsartan Tablets USP. Once again, NDEA contamination forced the company to act.
According to the Aurobindo’s recall notice, patients should not stop taking their medication before they obtain a replacement, as doing so could lead to serious adverse health consequences. Before returning recalled valsartan, affected patients should contact their pharmacist or physician to arrange for an alternative treatment.
Aurobindo was just one of the generic drug makers to recall tainted medications last year.
In June, Zhejiang Huahai Pharmaceutical Co. of China informed regulators around the world that it had detected another impurity – N-Nitrosodimethylamine (NDMA) – in its vasartan API.
NDMA is classified as a probable human carcinogen, and animal studies suggest exposure may cause tumors of liver, respiratory tract, kidney and blood vessels. Exposure to high levels of the chemical can also cause liver damage in humans.
Since Zehjiang Huahai disclosed the NDMA contamination, valsartan recalls have been announced by multiple generic drug makers in the United States and 21 other countries.
According to the U.S. Food & Drug Administration (FDA), NDMA likely resulted from a change in Zehjiang Huahai’s production methods that occurred in 2014. As such, tainted heart and blood pressure drugs may have been in circulation for the past four years.
The FDA placed Zehjiang Huahai on an import alert in September, which bans its drug products and API from entering the United States. The agency also issued a Warning Letter to the company in November, after an inspection found numerous quality control problems at its Chinese manufacturing plant.
At least a dozen valsartan lawsuits have been filed in relation to the NDMA recalls. In addition to Zehjiang Huahai, the complaints name various generic drug makers supplied by the Chinese company, as well as retailers that sold the medications. Although most of the pending complaints seek restitution for people who purchased recalled drugs, several plaintiffs claim the tainted valsartan caused cancer.
On January 31st, the U.S. Judicial Panel on Multidistrict Litigation (JPML) will hear Oral Arguments on a petition to centralize all federally-filed valsartan lawsuits in a single U.S. District Court.
Litigation involving NDEA-tainted drugs is also starting to grow in courts around the United States.
On December 1st, for example, Aurobindo was named in a class action complaint filed in the U.S. District Court, Middle District of Florida, on behalf of consumers who purchased medication manufactured with its irbesartan API.
In addition to the India-based company, the lawsuit also names Walmart, ScieGen Pharmaceuticals and Westminster Pharmaceuticals as defendants. (Case No. 8:18-cv-02927)
“Plaintiff and the putative class members were injured by paying the full purchase price of their medications containing Adulterated Irbesartan and by paying for incidental medical expenses,” the complaint states. “These medications are worthless because they are contaminated with carcinogenic and harmful NDEA and are thus not fit for human consumption.”