Valsartan Recall Issued For Mylan Products Contaminated With NDEA

Mylan is the latest of a growing number of generic drug manufacturers to issue a valsartan recall, indicating that 15 lots of it’s version of the widely used hypertension drug may contain a cancer-causing impurity, known as N-nitrosodiethylamine (NDEA). 

The FDA announced a Mylan recall for generic valsartan on November 20, indicating that traces amounts of NDEA was detected in the active ingredient pharmaceutical. The recall affects not only valsartan tablets, but also tablets that are a combination of valsartan and amlodipine, and valsartan and hydrochlorothiazide.

While there have been no adverse events or cases of cancer reported in connection with the recalled Mylan valsartan tablets to date, the impurity is a known human carcinogen.

NDEA occurs naturally in certain foods and drinking water, but can be created as a byproduct of industrial processes, which is what the FDA believes occurred in this instance and with other recent valsartan recalls linked to the presence of a similar impurity, N-nitrosodimethylamine (NDMA). Both are considered probably cancer-causing agents by the International Agency for Research on Cancer (IARC).

The latest recall affects 15 lots of Mylan Pharmaceuticals, Inc. products containing valsartan, including seven lots of Valsartan Tablets, USP, six lots of Amlodipine and Valsartan Tablets, USP, and two lots of Valsartan and Hydrocholrothiazide Tablets, USP. The recalled lots came in a variety of strengths and bottle sizes. The batches of valsartan affected by the recall were distrubited in the U.S. between March 2017 and November 2018. A complete list of the recently-recalled lots is published in the recall notice.

The recalled lots involved the use of batches of tainted valsartan manufactured by Mylan Pharmaceuticals, Inc. and Mylan Laboratories Limited. The company indicates it is notifying distributors and customers by letter and arranging for the return of the recalled products. The recall notice advises wholesalers, retailers and consumers in possession of recalled products to contact Stericycle by calling 1-888-406-9305 to arrange for the return of the products.

Valsartan Cancer Concerns

The announcement is the latest in a string of ongoing recalls affecting valsartan and other hypertension drugs which may be contaminated with NDMA or NDEA; impurities created during the manufacturing process.

The first valsartan problems surfaced on July 5, after European regulators announced that batches of the active ingredient supplied by Zhejiang Huahai Pharmaceuticals tested positive for NDMA.

The FDA followed with its own recall announcement on July 13, indicating that the agency had launched an investigation to determine the scope of the contamination and the potential risk to consumers.

In late September, the FDA stopped all imports of drug ingredients and medicines made by Zhejiang Huahai Pharmaceuticals, after an inspection report outlined a number of serious manufacturing problems at the company’s facility in late August.

The recalls have led to a valsartan shortage and a spike in prices, with the cost of 160 milligram and 80 milligram tablets of generic valsartan more than doubling in September 2018.

As consumers nationwide continue to face concerns about the safety of pills they have taken in recent years, a number of valsartan recall class action lawsuits have been filed nationwide, seeking damages for the cost of the recalled drugs and medical monitoring. For those diagnosed with liver cancer, kidney cancer, pancreatic cancer, stomach cancer and other cancers, individual cases are being reviewed by valsartan lawyers.

The FDA has assigned a group of pharmacists and nurses to answer consumer’s questions about the recalls. Since the first recalls, the agency indicates it has received more than 6,000 inquiries from patients, doctors, nurses, pharmacists and academics. Inquiries can be made by calling 855-543-3784 or by sending an email to druginfo@fda.hhs.gov.

Consumers are urged to contact their doctor if they have experienced any problems that may be related to the recalled valsartan. Healthcare professionals and patients are urged to report adverse events to FDA’s MedWatch adverse event reporting program.