Drug Safety and Availability > FDA updates on angiotensin II receptor blocker (ARB) recalls

Drug Safety and Availability > FDA updates on angiotensin II receptor blocker (ARB) recalls

FDA alerts patients and health care professionals to Sandoz’s losartan potassium and hydrochlorothiazide recall of one lot due to NDEA

Update [11/9/2018] FDA is alerting patients and health care professionals to Sandoz’s voluntary recall of one lot – JB8912 – of losartan potassium and hydrochlorothiazide 100mg/25mg tablets, that contain losartan, an angiotensin II receptor blocker (ARB), and hydrochlorothiazide, a diuretic, used in combination for the treatment of hypertension. Sandoz’s product was made using an active pharmaceutical ingredient (API) that has tested positive for NDEA. The API was manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd, which is on import alert.

Sandoz’s losartan drug products make up less than 1 percent of the total losartan drug products in the U.S. market.

FDA continues to investigate the presence of NDEA and NDMA, which are probable human carcinogens, in ARBs and is taking swift action when it identifies unacceptable impurities in API and finished drug products.

FDA reminds patients taking this medication or any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option. It also is important to know not all ARBs contain NDEA or NDMA, so pharmacists may be able to provide a refill of medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition.

---

The links below are to FDA-published testing methods to provide options for regulators and industry to detect NDMA and NDEA impurities. These methods should be validated by the user if the resulting data are used to support a required quality assessment of the API or drug product, or if the results are used in a regulatory submission.

• The combined headspace method is a GC/MS method that allows determination of both NDMA and NDEA simultaneously in sartan drug substance and drug products.
• The combined direct injection method is a GC-MS/MS method that allows for determination of both NDMA and NDEA simultaneously in sartan drug substance and drug products.

The European Directorate for the Quality of Medicines (EDQM) has also published methods to detect NDMA and NDEA. FDA has not validated EDQM's methods.