Detection of Impurity Prompts Company to Recall 1 Lot of Combination Tablets

Macleods Pharmaceuticals Limited has voluntarily recalled 1 lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level, due to the detection of trace amounts of an unexpected impurity found in the product that is above the acceptable daily intake levels released by the FDA.

The lot (#BLM715A, expiring July 2019) was manufactured with active pharmaceutical ingredient (API) made by Hetero Labs Limited.

The impurity detected is N-nitrosodiethylamine (NDEA), 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.

FDA Analysis Addresses ARB Impurity Risk to Patients

According to the FDA, Macleods had not received any reports of adverse events related to the recall at the time it was announced. However, consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Losartan potassium/hydrochlorothiazide combination tablets are indicated to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy. Patients who are taking this medication should continue, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.

The recalled medication was distributed nationwide to Macleods wholesale distributor and retail customers. It can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

Email recall@qualanex.com or call 888-280-2042 with any general questions regarding the return of this product.

Additional recalls related to API manufactured by Hetero Labs Limited were previously announced by the FDA. They include 16 lots of Torrent Pharmaceuticals’ losartan potassium tablets USP and losartan potassium and hydrochlorothiazide tablets USP.

Six Additional Lots of Losartan Tablets Recalled

Reference

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity [news release]. Silver Spring, MD; February 22, 2019: FDA website. http://www.pharmacytimes.com/link/259. Accessed February 2019.