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Recall 2018-202: Sandoz - Losartan - NYC - Consumer



Recall 2018-202: Sandoz - Losartan - NYC - Consumer

URGENT!!!            DRUG RECALL!!!            URGENT!!!

NDC
                             Label Name                                                  Lots                Expiration Date

00781520710               LOSARTAN-HCTZ 100-25 MG TAB            JB8912            06/30/2020



Sandoz is voluntarily recalling the above item/lot due to the presence of an impurity, NDEA (N-nitrosodiethylamine), identified during defined screening tests of Losartan API (active pharmaceutical ingredient) sourced from an external supplier.  This recall is to the Consumer level.  Affected product started shipping October 01, 2018.

Patients with questions regarding this recall can contact Sandoz Inc. at 1-800-525-8747 Monday-Friday 8:30 AM - 5:00 PM (EST) or email usdrugsafety.operations@novartis.com.  Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. 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 should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using Losartan Potassium Hydrochlorothiazide. Patients should return product to the pharmacy purchased from.

This recall is being conducted with the knowledge of the FDA.

Contact:

Sandoz Pharmaceuticals: Sandoz Customer Service 800-525-8747