Recall of Blood Pressure Medicines Due to Cancer Risk
Recall of Blood Pressure Medicines Due to Cancer Risk
56,000 bottles of blood pressure medication recalled
05 March, 2019, 22:43
The recalled 25 mg, 50 mg, and 100 mg tablets contained small quantities of N-Nitroso N-Methyl 4-aminobutyric acid, or NMBA, following a firm recall notice posted on the Food and Drug Administration's website.
Questions about the recalled blood pressure medication can be directed to Camber Pharmaceuticals' Med Line at 1-866-495-1995, Monday through Friday from 9 a.m.to 5 p.m. ET.
Camber Pharmaceuticals is pulling about 56,000 bottles of Losartan. The company said it hadn't received any reports of patients being harmed related to the recall.
The affected Losartan tablets have expiration dates that run from September 2019 through June 2020. Prinston Pharmaceutical identified China's Zhejiang Huahai Pharmaceuticals as the source of NDEA found in its hypertension medication recalled by the company last month.
Another blood pressure drug is being recalled after being found to contain trace amounts of a potentially cancer-causing ingredient, one of a slew of recalls of medications to treat hypertension. This is the first ARB recall resulting from the presence of NMBA, which is the third type of nitrosamine impurity detected in ARB medicines. The active drug ingredient was made at Hetero Labs Restricted in India, one in all two overseas drug factories linked to repeated blood treatment recollects since final July.
"The FDA is committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes in the future", he added.
"We are deeply concerned about the presence of a third nitrosamine impurity in certain ARB (angiotensin II receptor blocker) medications", FDA Commissioner Scott Gottlieb said in Friday's update on the problem, "but it's important to underscore that, based on the FDA's initial evaluation, the increased risk of cancer to patients with NMBA exposureappears to be the same for NDMA exposure but less than the risk from NDEA exposure".
From a community pharmacy perspective, this recall has been hard because many pharmacies don't keep the lot numbers of medications after they're dispensed, Freeman said: "That information is not tracked effectively".
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