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Recent Drug Recall on Losartan-Hydrochlorothiazide

Date: 11/15/18

Attention Members and Providers: MHS wants you to know about a recent drug recall.

On November 8, 2018, the FDA announced that Sandoz Inc. was recalling one lot of Losartan-Hydrochlorothiazide (HCTZ) tablets to the consumer level due to the presence of an unexpected impurity.

The FDA press release states the following:  Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide tablets, USP 100 mg/25 mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is 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 Inc. has not received any reports of adverse events related to this lot. Losartan Potassium Hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. 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.

If you have any questions or concerns about Envolve Pharmacy Solutions’ response to the product recall, please contact Nelson Aragon, Pharm.D., Drug Utilization Review Clinical Pharmacist, at 800.225.2573, ext. 809.3034 or e-mail at Nelson.Aragon@Envolvehealth.com, or contact Taline Jaghasspanian, Pharm.D., Senior Manager, Clinical Pharmacy Operations, at 818.676.6959, or email at Taline.Jaghasspanian@centene.com