American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity
American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. This recall is being initiated in response to the recall by the manufacturer (Aurobi...
Source: Food and Drug Administration - March 7, 2019 Category: Food Science Source Type: news
Blood Pressure Medication Recall Expands Again To Include Losartan
(CNN) — A widespread recall of common blood pressure and heart failure medications has been expanded to include more drugs containing losartan. The recall is due to an “impurity” that is classified as a potential human carcinogen.
The impurity, N-Nitroso-N-methyl-4-aminobutyric acid or NMBA, is also classified as a known animal carcinogen, the US Food And Drug Administration noted in a news release about the recall Friday.
Camber Pharmaceuticals Inc. voluntarily recalled 87 lots of losartan tablets in the United States on Thursday. The recalled tablets, made by Hetero Labs Ltd. In India and distributed by...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - March 1, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Consumer Health News FDA losartan Valsartan Source Type: news
AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.
AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18 The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) cl...
Source: Food and Drug Administration - March 1, 2019 Category: Food Science Source Type: news
Pfizer Japan recalls high blood pressure drug over cancer-causing impurity
The Japanese subsidiary of Pfizer Inc is recalling a drug for high blood pressure which was found to contain a carcinogenic substance in its active ingredient valsartan, the drugmaker said on Friday. (Source: Reuters: Health)
Source: Reuters: Health - February 8, 2019 Category: Consumer Health News Tags: healthNews Source Type: news
Go ahead for first add-on tablet to insulin treatment for type 1 diabetes
European regulator recommends dapagliflozin for those with poor blood glucose control despite best efforts Related items fromOnMedica Use of DPP-4 inhibitors associated with increased risk of IBD Adding insulin to metformin linked to higher mortality Draft diabetes guidance too heavily focused on cost, protests industry MHRA tightens licence restrictions on valproate for women Withdrawn valsartan meds not linked to short-term cancer risk (Source: OnMedica Latest News)
Source: OnMedica Latest News - February 5, 2019 Category: UK Health Source Type: news
Morning Break: Generic Advair; Polar Vortex Deaths; Valsartan Gouging
(MedPage Today) -- Health news and commentary from around the Web gathered by the MedPage Today staff (Source: MedPage Today Pediatrics)
Source: MedPage Today Pediatrics - January 31, 2019 Category: Pediatrics Source Type: news
Cancer Fears Have Triggered Blood Pressure Drug Recalls for Months. Now Patients Are ‘Leery’
Cynthia Brown had been taking the drug valsartan for about two years when she learned last August that it had been recalled over fears of potential carcinogen contamination. Brown, a writer and patient advocate living near Cincinnati, had been prescribed valsartan to control shortness of breath related to primary pulmonary hypertension, but suddenly she had a whole new concern: cancer.
“I’ve always been very conscientious about my health. I never dreamed I’d be on all these medications, and I’m real funny about what I take,” Brown, 65, says. “Valsartan has made me leery of all medication...
Source: TIME: Health - January 29, 2019 Category: Consumer Health News Authors: Jamie Ducharme Tags: Uncategorized Drugs healthytime Source Type: news
FDA warns of blood pressure med shortage
FDA Commissioner Scott Gottlieb and CDER Director Janet Woodcock released a statement warning of a shortage of ARBs, or angiotensin II receptor blockers, which contain valsartan. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 28, 2019 Category: Pharmaceuticals Source Type: news
FDA warns of common blood pressure medicine shortage due to recalls
The US Food and Drug Administration is warning of a shortage of a class of drugs used by millions to treat high blood pressure. The drugs known as ARBs, or angiotensin II receptor blockers, contain valsartan. (Source: CNN.com - Health)
Source: CNN.com - Health - January 27, 2019 Category: Consumer Health News Source Type: news
2 MILLION people have been exposed to cancer-causing chemicals in contaminated blood pressure drugs
Last summer, it emerged widely-prescribed drugs for heart failure and hypertension - including valsartan and irbesartan - had dangerously high levels of recognized carcinogens. (Source: the Mail online | Health)
Source: the Mail online | Health - January 25, 2019 Category: Consumer Health News Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on the FDA ’s ongoing investigation into valsartan and ARB class impurities and the agency’s steps to address the root causes of the safety issues
FDA describes the ongoing investigation into the ARB class impurities and agency ’s steps to address the root causes of the safety issues (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 25, 2019 Category: American Health Source Type: news
Some irbesartan medicines recalled
MHRA recall some blood pressure and heart medication because of contamination fears Related items fromOnMedica Blood pressure measurement Hypertension: what ’s new and how might this impact practice? Withdrawn valsartan meds not linked to short-term cancer risk Exercise may be as good at lowering blood pressure as drugs Treatment of hypertension for low-risk patients questioned (Source: OnMedica Latest News)
Source: OnMedica Latest News - January 7, 2019 Category: UK Health Source Type: news
Heart Drug Recall Expanded Again
(CNN) — The recall of popular heart drugs has expanded yet again.
The US Food and Drug Administration said Thursday that Torrent Pharmaceuticals has added eight additional lots of losartan potassium tablets to its recall list. Losartan potassium is a drug used to control high blood pressure. It is also used to treat kidney disease in patients with diabetes.
This recall includes 30-, 90- and 1,000-count bottles of 100-milligram tablets; 30-, 90- and 1,000-count bottles of 50-milligram tablets; and 90-count bottles of 25-milligram tablets. Torrent is recalling only these particular losartan potassium tablets. Tests fou...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - January 4, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News CNN Recall Valsartan Source Type: news
Heart drug recall expanded again
The recall of heart drugs has expanded again to include Torrent Pharmaceuticals losartan potassium and Aurobindo Pharma USA Inc. drugs containing valsartan. (Source: CNN.com - Health)
Source: CNN.com - Health - January 4, 2019 Category: Consumer Health News Source Type: news
More Tainted Valsartan Products Recalled More Tainted Valsartan Products Recalled
Aurobindo Pharma USA has recalled 80 lots of medicines containing valsartan, owing to the presence of the probable carcinogen N-nitrosodiethylamine (NDEA).News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 4, 2019 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news
