Skip to main content

May 23rd, 2014 Drug Alert: Hypertension drug PMS-Losartan-HCTZ recalled due to labelling error

May 23rd, 2014 Drug Alert: Hypertension drug PMS-Losartan-HCTZ recalled due to labelling error

PMS-Losartan-HCTZ 100/25mg is a combination product of both losartan (100 mg) and hydrochlorothiazide (HCTZ, 25mg) used for the treatment of hypertension (high blood pressure). One lot is being recalled due to a labelling error on the inner package or blister. Taking two 100/25mg tablets instead of one to obtain the correct amount of HCTZ would result in a double dose of both components (losartan and HCTZ) of this product and potential serious adverse effects. The possible risks of a double dose include hypotension (low blood pressure), fast heart rate, and depletion of electrolytes (or salts) in the body and dehydration.

Pharmascience Inc., in consultation with Health Canada, is recalling one lot of PMS-Losartan-HCTZ due to a labelling error on the blister pack. The printed boxes of the product show the proper dosage “Losartan-HCTZ100/25mg,” while some blisters or inner packages incorrectly say “Losartan-HCTZ 100/12.5mg.” The product is packaged with 100/25mg tablets. Taking more of the drug than prescribed could have serious health effects. The product affected is PMS-Losartan-HCTZ (Lot number: 0300804). If you are taking this product, check the packaging for the lot number. If this is the affected lot, return the product to your pharmacist and obtain a replacement.