Another blood pressure medication has been recalled over concerns it could contain trace amounts of carcinogens.
Camber's recall dwarfs the one by Macleods, as it involves various sizes of tablets (25mg, 50mg 100mg) in various sizes of bottles (30-count, 90-count, 500-count, 1,000-count). Here's a list of the latest products recalled.
The recall is the latest in an ongoing investigation into a class of drugs known as angiotensin receptor blockers or ARBs, which contain either valsartan, losartan or irbesartan and are used in patients with high blood pressure and other conditions.
The recalled losartan potassium tablets made by Hetero Labs and distributed by Camber Pharmaceuticals contain the impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).
Presently, Illinois-based compliance company Stericycle is working with Camber to notify distributors and customers of the recall.More news: Hillary Clinton confirms she is NOT running for president in 2020
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The FDA said increased risk of cancer in patients exposed to the new impurity, NMBA, appeared to be the same as those exposed to NDMA, but less than the risk from NDEA.
A series of drugs have been identified as potentially unsafe since an initial recall began seven months ago.
"Because of the potential for discovering other nitrosamine impurities, we are conducting an extensive organic chemistry analysis to develop novel testing methods to detect additional nitrosamine impurities, including NMBA".
AurobindoPharma, which recalled 80 lots of Valsartan medicines that had too much NDEA in January, added another 38 lots of Valsartan and Valsartan with Amlodipine tablets Friday.
"We are making important strides at understanding how these impurities form and we are continuing to examine if nitrosamine impurities may also arise during the manufacture of other ARB drug products", Gottlieb wrote. The full list can be seen here on the company's recall announcement on Thursday afternoon. Zhejiang Huahai has said it has been in close contact with the FDA since the recall began. Friday, Torrent recalled 60 lots of Losartan potassium tablets and 54 lots of Losartan potassium/hydrochlorothiazide tablets because of NMBA's presence.