Mylan has expended its valsartan recall to include all of its heart and blood pressure drugs that contain the potentially-contaminated ingredient.
However, the U.S. Food & Drug Administration (FDA) advised patients taking Mylan’s valsartan medications to continue using the drugs until they receive a replacement.
Mylan announced an initial recall last month for the following products:
On Wednesday, the Mylan recall was expanded to include 104 additional lots, including:
Valsartan recalls began in June, after Zhejiang Huahai Pharmaceutical Company discovered an impurity, N-nitrosodimethylamine (NDMA), in its API (active pharmaceutical ingredient).
The U.S. Environmental Protection Agency has declared NDMA a probable human carcinogen. Among other things, animal studies have linked the chemical to liver and kidney cancer.
Generic drug manufacturers in the United States and 21 other countries have since initiated valsartan recalls.
Prior to the recall, Zhejiang Huahai Pharmaceutical supplied roughly half of the valsartan API used by generic drug makers in this country. However, the FDA banned the company from importing drug products and API after an inspection uncovered quality control deficiencies at its manufacturing plant in China.
At least a dozen plaintiffs in the United States have filed valsartan lawsuits since the worldwide recall was announced.
The majority of claims are class actions that seek refunds for valsartan purchases, However, at least one complaint alleges that tainted valsartan was responsible for a patient’s death from kidney cancer.
The U.S. Judicial Panel on Multidistrict Litigation is considering a motion that seeks to centralize all federally-filed valsartan claims in a single U.S. District Court. Valsartan plaintiffs petitioned for centralization in October, asserting that the litigation would eventually grow to include hundreds of similar claims.
The creation of a multidistrict litigation would allow all cases in the federal valsartan docket to undergo coordinated discovery and other pretrial proceedings. Such proceedings are intended to promote judicial efficiency and preserve the resources of the court, parties and witnesses involved in the litigation.