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Two companies have issued recalls regarding many reconditioned hypertension medications involved in previous voluntary recalls due to the detection of an impurity greater than acceptable levels in the active ingredient.
Legacy Pharmaceutical Packaging announced two company announcements, in which one of them recalled 40 batches of repackaged losartan in 25mg, 50mg and 100mg doses, due to the voluntary recall of the distributor. Camber Pharmaceuticals, February 28, and in another He recalled three batches of reconditioned losartan tablets in 50 mg doses due to the voluntary recall of several batches of losartan tablets nationwide on March 1.
The two previous recalls were due to the detection of traces of N-methyl-4-amino butyric acid (NMBA) N-Nitroso in the active pharmaceutical ingredient manufactured by the Indian company Hetero Labs Limited.
NMBA is a potential human carcinogen in the class of chemical compounds called nitrosamines. To date, Legacy, based in St. Louis, has stated that he has not received any reports of adverse events related to his recall.
American Health Packaging has announced the voluntary recall of a batch of valsartan tablets at a dose of 160 mg, at the request of the manufacturer AurobindoPharma USA, voluntarily recalling March 1 additional lots of valsartan due to the detection of N-Nitrosodiethylamine (NDEA) in the active principle.
A number of drugs belonging to the class of angiotensin II receptor antagonists have been voluntarily recalled since July due to the detection of unacceptable levels of NDEA and / or N-nitrosodimethylamine (NDMA) and, more recently, NMBA, in their active activity. pharmaceutical ingredient such as losartan, valsartan or irbesartan.
NDMA and NDEA are also chemical compounds of the nitrosamine class and both are considered a likely risk of cancer in humans at certain levels of exposure.
Voluntary booster drugs block receptors in the body that contribute to conditions such as hypertension. The Food and Drug Administration, which has published acceptable intake levels for these nitrosamines that may result from the manufacturing process, is working with their manufacturers to update, reduce, and eliminate tests.
He also referred consumers to his recall lists and recommended frequent checks for additional additions.
On March 12, the FDA announced that it was giving priority to the approval of another generic version of Diovan, valsartan, in recognition of multiple drug recalls containing ARBs. on impurities of nitrosamine. The first voluntary recall in July concerned an NDMA impurity detected in valsartan, the active pharmaceutical ingredient.
"We know that ongoing recalls to prevent certain lots of valsartan containing unacceptable limits of impurities from reaching patients have resulted in a shortage of these important medications," said Dr. Scott Gottlieb, outgoing commissioner from the FDA, in a prepared statement.
"So, to deal with the consequences of these shortages on public health, we have prioritized the review of generic applications of these valsartan-based products."
The approval of the new generic drug was granted on March 12 to the Indian company Alkem Laboratories Limited.
According to the press release, the FDA has evaluated the company's manufacturing processes and has also made sure "that it has used proper testing methods to demonstrate that the valsartan product approved today does not contain NDMA or NDEA ".
He added that "the FDA's assessment of the manufacturing processes of the product determined that there was no known risk of formation of nitrosaminic impurities".
Alkem, which has developed facilities for the US market, has two FDA-approved production sites in India, a production facility in St. Louis and a pharmaceutical active ingredients manufacturing facility in California.
In the March 15 announcement, in response to the Torrent recall, the FDA indicated on its website that Legacy Pharmaceutical was informing its distributors and customers in writing and organizing / assisting the return of all recalled products to Inmar Pharmaceutical Services.
The FDA also released its second announcement on March 15 in response to the Camber recall. It also states that Legacy sends notification letters regarding these reminders.
In the March 7 announcement by the FDA on its website, American Health Packaging said the product it recalled had been distributed to wholesalers nationwide for use in hospitals and that It had not been reported so far neither injury nor adverse event.
According to the newspaper, the patients to whom the recalled tablets were prescribed should continue to take their medications, as the risk of harm may be higher if the treatment is stopped immediately without further treatment. Patients should contact their pharmacist or doctor for alternative treatment.
In announcing the approval of the new generic, the FDA has announced that it will continue to update the lists of its recalled products, Valsartan, Astartan and Irbesartan, as new information becomes available during testing. In progress. The date is shown at the top to indicate when the lists have been updated.
He advised patients taking an ARB medication to periodically check lists, "information may change" and noting that all "ARA drugs have not been recalled".
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