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Both Losartan Potassium and Losartan Potassium/Hydrochlorothiazide combination tablets are used to treat hypertension and hypertensive patients with left ventricular hypertrophy.
- India-based Vivimed Life Sciences Pvt Ltd is recalling 19 lots of Losartan Potassium Tablets USP 25 mg, 50 mg, and 100 mg to consumer level due to the detection of N-Nitroso-N-methyl-4-aminobutyric acid, a possible process impurity or contaminant in an active pharmaceutical ingredient manufactured by Hetero Labs Ltd (API manufacturer), that is above the US Food and Drug Administration's interim acceptable exposure limit of 9.82 ppm, the company said.
The bulk lots of losartan potassium tablets were sold exclusively to Golden State Medical Supply, Inc., which packaged and distributed the medication for retail in bottles of 30, 90, and 1,000 tablets.
Losartan Potassium and HCTZ Tablets, 50 mg/12.5 mg and 100 mg/25 mg, recorded US sales of approximately USD570m for the 12 months ending 30 June 2010 and Losartan Potassium Tablets had US sales of approximately USD940m in the same period, according to IMS Health.
Another Losartan Potassium recall has been issued following two other ( recalls for blood pressure medication made over the last few weeks.
M2 PHARMA-April 29, 2019-Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg and 100 mg Tablets USP
They included anastrozole tablets; codeine sulfate tablets NDA; imipramine pamoate capsules; losartan potassium tablets USP; losartan potassium and hydrochlorothiazide tablets 50 mg/12.5 mg and 100 mg/25 mg; losartan potassium and hydrochlorothiazide tablets 100 mg/12.5 mg; morphine sulfate 100 mg/5mL (20 mg/mL) oral solution NDA; naratriptan tablets USP; oxymorphone hydrochloride tablets; and valacyclovir hydrochloride tablets
Pharmaceutical company Teva Pharmaceutical Industries Ltd (Nasdaq:TEVA) declared on Wednesday the receipt of final approval from the US Food and Drug Administration for the company's generic versions of Merck's antihypertensive agents Hyzaar (hydrochlorothiazide; losartan potassium) and Cozaar (losartan potassium).
The recalled medication includes Losartan potassium tablets USP and Losartan potassium/hydrochlorothiazide tablets, USP, which may contain an impurity that could cause cancer.
Merck & Co Inc's (NYSE: MRK) Hyzaar is known generically as Losartan Potassium and Hydrochlorothiazide (HCTZ) Tablets and Merck Research Laboratories' Cozaar is known generically as Losartan Potassium Tablets.
Losartan Potassium USP tablets are used to treat high blood pressure and congestive heart failure.