New Source of Contaminated Valsartan Identified
August 9, 2018 – Camber Pharmaceuticals, Inc., has recalled all unexpired lots of its 40mg, 80mg, and 160mg valsartan tablets due to N-nitrosodimethylamine (NDMA) contamination.
The recalled products from Camber Pharmaceuticals contain an active pharmaceutical ingredient (API) that may have been contaminated with NDMA through the manufacturing process at the ingredient supplier, Hetero Labs Limited. Hetero Labs, based in India, is Camber Pharmaceuticals’ parent company. Not all valsartan-containing products bearing the Camber Pharmaceuticals label have been affected.
Prior to this recall, only products that contained an API sourced from China’s Zhejiang Huahai Pharmaceutical had been identified as containing NDMA. Both Hetero Labs and Huahai Pharmaceutical use similar manufacturing processes. The FDA is looking into the manufacturing processes at other valsartan API suppliers to evaluate and prevent the risk of NDMA contamination. The FDA is also investigating whether other types of angiotensin receptor blockers (ARBs) may be vulnerable to NDMA contamination through manufacturing processes.
Updates on recalled valsartan products and the FDA’s ongoing investigation can be found at: