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A Second Impurity Found in Recalled Valsartan Drug Products

NDEA, a Known Carcinogen, Discovered During FDA Testing

The FDA has discovered a new impurity in three lots of Torrent Pharmaceuticals’ recalled valsartan drug products. This second impurity, N-Nitrosodiethylamine (NDEA), is a known animal and suspected human carcinogen. These Torrent products were included in the company’s earlier recall on August 23, 2018.

The FDA and the European Medicines Agency have learned that Zhejiang Huahai Pharmaceuticals (ZHP) found NDEA in several batches of its drug containing valsartan as the active pharmaceutical ingredient (API). The FDA immediately began retesting all valsartan API and products, including both recalled products and those currently marketed in the United States, for NDEA. Based on FDA testing to date, the agency discovered NDEA in some of ZHP’s valsartan API. This impurity was also found in Torrent’s valsartan 160 mg (lot BV47D001) and 320 mg (lots BV48D001 and BV48D002) tablets, which were made using valsartan API from ZHP and were part of the earlier recall. The FDA’s testing shows that not all products made using ZHP’s valsartan API contain the NDEA impurity. 

The FDA will update the list of products included in the recall (and those not included in the recall) as products are tested for NDEA and as more information becomes available. At this time, the FDA’s testing supports the conclusion that not all valsartan products contain NDEA, so pharmacists may be able to provide a valsartan medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition.

Source: FDA.gov, September 13, 2018

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