BRIEF—FDA updates on recalled valsartan-containing product

In the ongoing worldwide recall of an off-patent blood pressure drug, another manufacturer has been added.

Yesterday, the US Food and Drug Administration alerted health care professionals and patients that Indian drugmaker Torrent Pharmaceuticals is voluntarily recalling 16 lots of valsartan/amlodipine tablets and valsartan/amlodipine/hydrochlorothiazide (HCTZ) tablets.

Not all Torrent valsartan products distributed in the US are being recalled.

The FDA recently learned Torrent used affected valsartan active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals.

FDA testing confirmed NDMA in some Torrent products.

To date, Torrent has not received any reports of adverse events related to this recall.

The FDA has updated the list of valsartan products under recall and the list of valsartan products not under recall to incorporate additional repackagers of Camber’s valsartan products and Torrent’s recall.