PhotoMacleods Pharmaceuticals Limited is recalling Losartan Potassium tablets and Losartan Potassium/Hydrochlorothiazide combination tablets used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy.

The products contain trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA), a potential human carcinogen.

The firm has not received any reports of adverse events to date.

The following products, packaged in bottles, are being recalled:

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
 

The products can be identified by checking the product name, manufacturer details and batch or lot number on the bottle.

What to do

Patients who are on the recalled medications should continue taking them 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.

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

Macleods is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

Consumers with general questions regarding the return of the recalled product may contact Qualanex (888) 280-2046, 7:00 am to 4:00 pm (CST) Monday – Friday or by email at recall@qualanex .com.


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