Another Blood Pressure Medication Recalled Due to Carcinogen Risk

Macleods Pharmaceuticals Limited has initiated a voluntary recall in the United States, to the patient level, of 32 lots of Losartan Potassium USP Tablets (2 lots of 50mg strength) and Losartan Potassium/Hydrochlorothiazide combination Tablets (12 lots  of  50mg/12.5mg strength, 3 lots of 100mg/12.5mg strength and 15 100mg/25mg strength) to the patient level due to the detection of trace amounts of an unexpected impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The impurity was found in 32 lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out.

Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide combination Tablets are indicated to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy. Patients who are on Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide combination Tablets, USP should continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.

To date, Macleods Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

The products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

Losartan Potassium Tablets 50 mg
NDCManufacturerProduct DescriptionLot/BatchExpiration Date
33342-045-10Macleods Pharmaceuticals LimitedLosartan Potassium.Tablets USP 50mg 90ctBLl711ANov-19
33342-045-44Macleods Pharmaceuticals LimitedLosartan Potassium Tablets USP 50mg 1000ctBLl710ANov-19
Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg
NDCManufacturerProduct DescriptionLot/BatchExpiration Date
33342-050-10Macleods Pharmaceuticals LimitedLosartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mgBLK719ASep-19
33342-050-10Macleods Pharmaceuticals LimitedLosartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mgBLK720ASep-19
33342-050-10Macleods Pharmaceuticals LimitedLosartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mgBLK721ASep-19
33342-050-10Macleods Pharmaceuticals LimitedLosartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mgBLK722ASep-19
33342-050-10Macleods Pharmaceuticals LimitedLosartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mgBLK723ASep-19
33342-050-10Macleods Pharmaceuticals LimitedLosartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mgBLK724ASep-19
33342-050-10Macleods Pharmaceuticals LimitedLosartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mgBLK725AOct-19
33342-050-10Macleods Pharmaceuticals LimitedLosartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mgBLK726AOct-19
33342-050-10Macleods Pharmaceuticals LimitedLosartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mgBLK804AJan-20
33342-050-10Macleods Pharmaceuticals LimitedLosartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mgBLK806AJan-20
33342-050-10Macleods Pharmaceuticals LimitedLosartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mgBLK825AOct-21
33342-050-10Macleods Pharmaceuticals LimitedLosartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mgBLK826AOct-21
Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 12.5 mg
NDCManufacturerProduct DescriptionLot/BatchExpiration Date
33342-051-10Macleods Pharmaceuticals LimitedLosartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 12.5 mgBLL801ADec-19
33342-051-10Macleods Pharmaceuticals LimitedLosartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 12.5 mgBLL802ADec-19
33342-051-10Macleods Pharmaceuticals LimitedLosartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 12.5 mgBLL803ADec-19
Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg
NDCManufacturerProduct DescriptionLot/BatchExpiration Date
33342-052-10Macleods
Pharmaceuticals Limited
Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mgBLM716AJul-19
33342-052-10Macleods
Pharmaceuticals Limited
Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mgBLM717AJul-19
33342-052-10Macleods
Pharmaceuticals Limited
Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mgBLM719AAug-19
33342-052-10Macleods
Pharmaceuticals Limited
Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mgBLM720AAug-19
33342-052-10Macleods Pharmaceuticals LimitedLosartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mgBLM721ASep-19
33342-052-10Macleods Pharmaceuticals LimitedLosartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mgBLM722ASep-19
33342-052-10Macleods
Pharmaceuticals Limited
Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mgBLM723AOct-19
33342-052-10Macleods
Pharmaceutica Is Limited
Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mgBLM724AOct-19
33342-052-10Macleods Pharmaceutical LimitedLosartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mgBLM725AOct-19
33342-052-10Macleods Pharmaceuticals
Limited
Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mgBLM726ANov-19
33342-052-10Macleods
Pharmaceuticals Limited
Losartan Potassium and Hydrochlorothiazide Tablets 100 mg 25 mgBLM802ADec-19
33342-052-10Macleods Pharmaceutical LimitedLosartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mgBLM803ADec-19
33342-052-10Macleods Pharmaceuticals
Limited
Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mgBLM825ASep-21
33342-052-10Macleods Pharmaceuticals
Limited
Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mgBLM826ASep-21
33342-052-10Macleods Pharmaceuticals LimitedLosartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mgBLM827ASep-21

 

Losartan Potassium Tablets 50mg and Losartan Potassium/Hydrochlorothiazide combination Tablets 50mg/12.5mg, 100mg/25mg and 100mg/12.5mg  were distributed nationwide to Macleods wholesale distributor and retail customers. Macleods Pharmaceuticals Limited is notifying its distributors and customers by phone and/or in writing to immediately discontinue distribution of the specific lot being recalled and to notify their sub-accounts. Macleods is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products  are given in the recall letter.

Consumers with medical questions regarding this recall or to report an adverse event can contact Macleods Pharmaceuticals Limited at 855-926-3384 (8:00 am – 5:00 pm EST).

If you have any general questions regarding the return of this product, please contact Qualanex via email at recall@qualanex .com or call 888-280-2046 (7:00 am to 4:00 pm CST Monday to Friday).

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Read more from the Original Report

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