Sandoz Recalls Lot of Losartan

Sandoz Inc. is voluntarily recalling one lot of hypertension drug Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API. Losartan API USP is manufactured by Zhejiang Huahai Pharmaceutical Co. Sandoz Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. The impurity, a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

To date, Sandoz has not received any reports of adverse events related to this lot.

The product can be identified as Losartan Potassium Hydrochlorothiazide, 100 mg/25 mg tablets in 1000-count plastic bottles, NDC 0781-5207-10, Lot number JB8912; Exp. Date 06/2020. This product was distributed nationwide to distributors. The affected product was not distributed prior to October 8, 2018.

Sandoz Inc. is notifying its distributors by letter via overnight mail and patients by this public notification. Distributors and retailers that have product which is being recalled should immediately stop distribution of the identified lot above and quarantine any quantities remaining in your control and return the recalled product to the identified Reverse Distributor.