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Specifically, Torrent Pharmaceuticals is recalling its losartan potassium tablets (100 mg/5 mg) for use in adults with high blood pressure, sold under the brand names Diovan, Duomax, Bystolic, Hyzaar, and Combunox (distributed globally to 117 countries).
FDA has alerted pharmaceutical manufacturers of drugs for hypertension that the new massive voluntary recall has been expanded, and is now includes 114 lots of losartan potassium, 28 lots of losartan potassium/hydrochlorothiazide, and four lots of losartan-based chewable tablets. This recall is due to unacceptable amounts of a preservative, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), in the losartan active pharmaceutical ingredient manufactured by Hetero Labs Limited.
The FDA is alerting patients and health care professionals to a voluntary recall of one lot of losartan potassium/hydrochlorothiazide (HCTZ) 100mg/25mg combination tablets manufactured by Macleods Pharmaceuticals. The recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) found in the medicine made with active pharmaceutical ingredient manufactured by Hetero Labs Limited.
The Project Management team offers decades of environmental testing experience and education to support your research project even the ones that push the envelope! Our scientists can provide in-depth technical expertise, troubleshoot issues, or refine your projects scope. Torrent Environmental Lab is your partner in problem-solving. Contact us today and well show you how our services will benefit your projects.
Update [6/26/2019] FDA is alerting patients and health care professionals to Macleods Pharmaceuticals voluntary recall of two lots of losartan potassium tablets (50mg strength) and 30 lots of losartan potassium/hydrochlorothiazide (HCTZ) combination tablets (12 lots of 50mg/12.5mg strength, three lots of 100mg/12.5mg strength, and 15 lots of 100mg/25mg strength). This recall is due to unacceptable amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) in the losartan active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.
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