Pharmacy Services Alerts
Losartan Potassium - Hydrochlorothiazide Recall - Raw Ingredient May Contain a Potential Carcinogen
Nov 21, 2018 8:31 AM
In November 2018, Sandoz Inc. voluntarily recalled tablets of losartan potassium co-formulated with hydrochlorothiazide. The recall affects one lot of losartan potassium – hydrochlorothiazide 100 mg/25 mg 1000-count bottles (NDC 0781-5207-10; Lot JB8912) distributed after October 8, 2018. One of the raw ingredients, losartan, USP, made by Zhejiang Huahai Pharmaceutical Co. contains the contaminant N-nitrosodiethylamine (NDEA). The International Agency for Research on Cancer classifies NDEA as a probable human carcinogen. Losartan potassium – hydrochlorothiazide is labeled to treat hypertension. No adverse events have been reported at this time.
Pharmacies should cease distribution of, and quarantine all affected products. Return the recalled product per the instructions of each individual supplier. Patients should continue taking their medication until they can contact their healthcare provider to discuss alternative options. Patients with questions or concerns about this recall can contact Sandoz Inc. at 800-525-8747 or by email at firstname.lastname@example.org. Consumers should report any adverse reactions from this product to their provider. Reactions may be reported to FDA through the MedWatch Adverse Event Reporting program at www.fda.gov/safety/medwatch/.
- Sandoz Inc. press release – November 8, 2018
- FDA updates on angiotensin II receptor blocker (ARB) recalls
- FDA Q&A on impurities found in ARB products