Action is taken after drugs are produced with trace amounts of NDEA.
One lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg, indicated for the treatment of high blood pressure, is being voluntarily withdrawn at the consumer level by Sandoz Inc. No adverse effects have been reported to date.
The company detected a trace amount of the impurity N-nitrosodiethylamine (NDEA) in the active pharmaceutical ingredient supplied by Zhejiang Huahai Pharmaceutical Co. Ltd. used to manufacture the drug. The formulated drug product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia.
NDEA has been classified as a probable human carcinogen as per the International Agency for Research on Cancer (IARC). It occurs naturally in certain foods and can be found in drinking water, air pollution and certain industrial processes.
The product that has been recalled is identified as follows: 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 on or after October 8, 2018.
All distribution of the product with this lot number should be halted and the product should be quarantined and returned to the identified Reverse Distributor.
Patients who are on Losartan Potassium Hydrochlorothiazide should continue taking their medication, as the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients that have product with the recalled lot number should call their pharmacist or physician for recommendations of alternative medications. The recalled product should be returned to Sandoz once patients have an alternative medication.
Any patients with questions about the recall should contact Sandoz Inc. at 1-800-525-8747 Monday-Friday 8:30 AM – 5:00 PM (EST) or email firstname.lastname@example.org. They should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using Losartan Potassium Hydrochlorothiazide. Adverse reactions should also be reported to the US Food and Drug Administration’s MedWatch Adverse Event Reporting program either by phone, online, by regular mail or by fax.