FDA Announces Manufacturer Recall of Valsartan Products

Released: 07/13/2018   By: Heidi Dufrene, PharmD

The medications, Valsartan and Valsartan-Hydrochlorothiazide, are being recalled by Prinston Pharmaceutical Inc. These medications may be manufactured by Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals. Currently, the recall is voluntary and only at the retail level. Valsartan products not manufactured by the above companies are not being recalled at this time. Valsartan and Valsartan-Hydrochlorothiazide are indicated for the treatment of hypertension and heart failure.

According to the FDA’s website, “This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. — that is used in the manufacture of the subject product lots. This impurity has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

The FDA announcement states, “The exposure to the impurity N-nitrosodimethylamine (NDMA) that was detected in valsartan product line presents an unacceptable carcinogenic risk to the intended patient population. To date, Prinston Pharmaceutical Inc. has not received any reports of adverse events related to this recall.”

At this time, all lot numbers from Prinston Pharmacetuical Inc. are being recalled. Retail pharmacies should immediately remove the affected medication from the shelf and return unused product. Patients with concerns regarding this recall should contact their doctor or pharmacist.

For further information about this recall, please reference the below link to the FDA’s website: