Valsartan-Containing Product Recall Expanded by FDA

The ongoing Food and Drug Administration (FDA) product recall of valsartan-containing products now includes Camber Pharmaceuticals brands.

On August 9, 2018, the FDA updated the list of valsartan products under recall and the list of valsartan products not under recall.

This FDA update incorporates recalls of valsartan-containing products manufactured by Hetero Labs Limited, in India, labeled as Camber Pharmaceuticals Inc.

But, this FDA recall does not include every Camber valsartan product distributed in the USA.

Camber Pharmaceuticals is voluntarily recalling certain valsartan tablets because they contain the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API).

Recalled valsartan products labeled as Camber may be repackaged by other companies. FDA will provide updates as more information becomes available.

As of this press release, Camber has not received any reports of adverse events related to this recall.

As a precautionary measure, Camber is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level.   

This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited. 

NDMA is classified as a probable human carcinogen, as per the International Agency for Research on Cancer (IARC) classification.

Hetero Labs manufactures the API for the Camber products, using a process similar to Zhejiang Huahai Pharmaceuticals.

Previously, the FDA announced on July 13th the recall of non-expired products that contain the ingredient valsartan, supplied by Zhejiang Huahai Pharmaceuticals, Linhai, China.  

Test results from Hetero Labs show the amount of NDMA found in its valsartan API exceeds acceptable levels; although it is generally lower than the amount discovered in the API manufactured by Zhejiang.

FDA is testing samples of valsartan API and finished products to confirm the extent and amount of NDMA and help inform the ongoing investigation.

The agency has also contacted other manufacturers of valsartan API to determine if their manufacturing processes are at risk for the formation of NDMA, and is working with them to ensure NDMA is not present in future valsartan API.

Valsartan Tablets, USP, is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct bottles & 90ct bottles. 

Valsartan is an angiotensin II receptor blocker (ARB), and FDA is investigating whether other types of ARBs are at risk for the presence of NDMA.

Consumers and healthcare professionals should report any adverse reactions with valsartan-containing products, to the FDA’s MedWatch program to help the agency better understand the scope of the problem.