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A voluntary recall of drugs for high blood pressure by Torrent Pharmaceuticals, March 1, will be extended by the company after the detection of an impurity of nitrosamine, according to an update and an announcement from the Food and Drug Administration of April 19th.
The FDA update has also released new "test methods" for what it now calls the "multiple nitrosamine impurities" associated with ongoing reminders of certain heart medications.
Torrent is recalling an additional 104 batches of losartan potassium and losartan potassium / hydrochlorothiazide combination tablets due to the presence of N-nitroso-N-methyl-4-aminobutyric acid (NMBA), beyond the permitted limits for the active pharmaceutical ingredient (rhombus) manufactured at Losartan by Hetero Labs Limited.
NMBA, a chemical compound of the nitrosamine class, is considered a potential carcinogen for humans.
The March 1 recall by Torrent involved 60 batches of losartan potassium tablets and 54 batches of losartan / hydrochlorothiazide potassium tablets due to detection of NMBA in thenartan manufactured by Hetero, above the daily intake levels. authorized by the FDA.
This recall involves a further 36 batches of losartan potassium tablets and 68 batches of losartan potassium / hydrochlorothiazide tablets.
About 40 voluntary recall of distributors and drug manufacturers belonging to the class of angiotensin II receptor blockers (ARBs) have occurred since July due to the detection of unacceptable levels of nitrosamines in their active ingredient, like losartan, valsartan or irbesartan.
The NMBA became the third nitrosamine impurity to be detected in an ARB drug in February, and the FDA announced in its Torrent Extended Reminder Update that it was publishing new test methods that "can help manufacturers and international regulators to detect and identify multiple impurities of nitrosamine. "
N-nitrosodiethylamines (NDEA) and / or N-nitrosodimethylamines (NDMA) previously detected in the APIs in this class of drugs were superior to the detected nitrosamines.
NDEA and NDMA are considered a probable carcinogen for humans.
The reminders prompted the FDA to launch tests on all ARB-containing drugs on the market, to establish acceptable intermediate levels in an API for dockage and to warn manufacturers upstream of their liability for drug-related problems. Update test methods and correct manufacturing processes produce these impurities as a byproduct of creating an active pharmaceutical ingredient.
The FDA's update of April 19 announced the release of "new test methods that can help manufacturers and international regulators detect and identify several nitrosamine impurities".
Its site also contains lists of recalled products and a list that consumers can check to see if the FDA's review of their ARA medications is associated with any recall has been completed and if no such impurity has been found or is incomplete, but the "product remains acceptable for distribution and for the use of the patient. "
ARA medications are prescribed to block the body's receptors that contribute to cardiovascular diseases such as high blood pressure.
The FDA update reminds patients whose antiretroviral drugs are being recalled to continue taking their current medications until their pharmacist replaces one or their doctor prescribes another medication that addresses the same problem. .
The Torrent announcement revealed that the company "has not received any reports of adverse events related to this recall" and includes a list of products included in the expanded recall.
In February, Camber Pharmaceuticals issued a voluntary recall of 87 batches of losartan potassium tablets at various doses, stating that the recalled losartan and potassium / hydrochlorothiazide potassium tablets manufactured by Hetero and distributed by Camber contained NMBAs above acceptable levels. in the IPA.
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