Drug Safety Alerts

Macleods Pharmaceuticals Losartan Potassium and Hydrochlorothiazide 100 mg/25 mg tablets Consumer-Level Recall

02/21/2019

On February 21, 2019, Macleods Pharmaceuticals issued a consumer-level recall of losartan potassium and hydrochlorothiazide 100 mg/25 mg tablets. This recall was issued due to the detection of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. Macleods is recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg that contains NDEA above the interim acceptable daily intake levels release by the FDA.

This recall affects lot number BLM715A exp 07/2019. No other lots are affected by this recall.

Losartan Potassium/Hydrochlorothiazide combination tablets are used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy. Patients who are on Losartan Potassium/Hydrochlorothiazide combination tablets should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, Macleods has asked that you please contact Qualanex at 1‑888-280-2042, Monday through Friday, 7:00 am to 4:00 pm (CT) or email them at recall@qualanex.com. You may also contact the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.fda.gov.