Mylan Recalls All Valsartan-Containing Heart and Blood Pressure Drugs

Published on December 6, 2018 by Sandy Liebhard

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.

Latest Mylan Valsartan Recall Includes 104 Additional Lots

Mylan announced an initial recall last month for the following products:

• 6 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths)
• 7 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths)
• 2 lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength

On Wednesday, the Mylan recall was expanded to include 104 additional lots, including:

• 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths)
• 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths),
• 27 lots of Valsartan and Hydrochlorothiazide Tablets, USP (80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg strengths).

What is the Valsartan Recall About?

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.

Valsartan Lawsuits Mount in U.S. Courts

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.