Valsartan Tablet Recall Expanded, More Manufacturers Linked To Cancer Risks

Amid continuing concerns about the risk that generic valsartan tablets may cause cancer, new reports suggest that the problems may be more widespread than initially feared, with regulators indicating that at least two additional manufacturers sold versions of the hypertension drug that contained cancer-causing impurities. 

On August 8, the FDA announced a Camber Pharmaceuticals valsartan tablet recall, after trace amounts of N-nitrosodimethylamine (NDMA) were detected in the company’s generic version of the drug. However, these tablets were not made by the same manufacturer as the previous valsartan recalls, which were first announced last month.

According to an FDA valsartan update, Camber Pharmaceuticals’ valsartan tablets were manufactured by Hetero Labs in India. The previous recalls all involved products manufactured by Zhejian Huahai Pharmaceuticals in China. However, the FDA indicated that the companies used similar manufacturing processes, resulting in the NDMA impurities in their drugs.

In addition, the European Medicines Agency (EMA) issued a press release on Friday, announcing NDMA had been detected in yet another manufacturer’s valsartan products; Zhejiang Tianyu of China.

In the cases of both Hetero Labs and Zhejiang Tianyu, U.S. and European regulators said the levels of NDMA they detected were lower than those in drugs manufacturerd by Zhejian Huahai, but the findings have led to increased concerns about the risk of of cancer that users of the generic valsartan tablets may have faced in recent years.

The initial generic Diovan (valsartan) recall was announced by the EMA on July 5, after batches of the active ingredient, supplied by Zhejiang Huahai Pharmaceuticals in China, tested positive for NDMA, which has been linked to a risk of liver cancer, kidney cancer and other types of cancer. That recall affected about 2,300 batches of valsartan and valsartan HCT shipped throughout Europe and Canada.

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

The agency has determined that the Chinese manufacturer has been distributing the contaminated pills for at least four years. Like the EMA, the FDA also noted NDMA has been linked to cancer risks in animal studies and that the U.S. Environmental Protection Agency (EPA) determined that consuming up to 96 nanograms of NDMA per day is considered reasonably safe for human ingestion.

Camber Pharmaceuticals Valsartan Recall

The latest recall by Camber Pharmaceuticals affects all unexpired lots of 40mg, 80mg, 160mg and 320mg valsartan tablets sold at the retail, consumer and hospital level. The 40mg tablets have an NDC Number of 31722-745-30, the 80mg tablets have an NDC Number of 31722-746-90, the 160mg tablets have an NDC Number of 31722-747-90, and the 320mg tablets have an NDC Number of 31722-748-90. All of the recalled tablets have expiration dates ranging from 07/2018 to 06/2020.

Consumers with questions regarding the recall can contact Qualanex, LLC by calling 1-800-505-9291 or by sending an email to recall@qualanex.com. The FDA requests that any consumers or healthcare providers who experience an adverse event linked to the recalled products file a report with the FDA’s MedWatch Adverse Event Reporting program.

A number of consumers who have been diagnosed with liver cancer, kidney cancer, lung cancer or suffered an acute liver injury in recent years are now reviewing whether they may be eligible for compensation through a valsartan lawsuit against the manufacturers of the generic drug, with lawyers providing free consultations and case evaluations for individuals nationwide.