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The FDA alerts patients and health professionals about a voluntary recall of 44 batches of losartan potassium tablets from Teva Pharmaceuticals USA bearing the Golden State Medical Supply Appellation because of the detection of the impurity, the N-Nitroso-N-methyl-4-aminobutyric acid. (NMBA) in the active pharmaceutical ingredient (API).
NMBA, a chemical compound of the class nitrosamines, is considered a potential carcinogen for humans at certain levels of long-term exposure.
This is the most recent nitrosamine impurity for which the FDA has set limits in ongoing recalls regarding the class of high blood pressure medications known as angiotensin II receptor blockers (ARBs). since July due to the detection of unacceptable levels of nitrosamines in their active pharmaceutical ingredient, such as losartan, valsartan or irbesartan.
The API in the current recall of Teva was manufactured by Hetero Labs, a company based in India.
Teva stated that NMBA was found in six batches of valsartan above the FDA's provisional acceptable exposure limit of 9.82 ppm. Based on the information available, the risk of developing cancer in some patients after long-term use of the product can not be ruled out.
In addition, the FDA's alert indicated that Legacy Pharmaceuticals Packaging was extending a previous recall to include an additional batch of losartan tablets due to the presence of NMBA in the IPA manufactured by Hetero.
In its statement, Legacy announced that it was expanding its March 19 consumer recall of three batches of 50 mg of repackaged losartan tablets in conjunction with the March Volunteer National Voluntary Recall of Torrent Pharmaceuticals to include an additional batch.
On March 1, Torrent issued a recall regarding 60 batches of losartan potassium tablets and 54 batches of potassium / hydrochlorothiazide tablets of losartan due to the presence of NMBA in the IPA manufactured by Hetero and extended the recall of April 19, 104 additional batches of losartan tablets the same reason.
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 drugs containing ARB on the market, to establish acceptable interim levels in an IPA for impurities and to warn foreign manufacturers involved of their liability for the use of the product. update test methods and correct manufacturing processes that may generate impurities. produce these impurities as a by-product of the creation of an active pharmaceutical ingredient.
To date, Legacy has stated that it has not received any reports of adverse events related to this recall.
Losartan potassium is a prescription medication used to treat high blood pressure and congestive heart failure.
Teva stated that its voluntary recall involved 35 lots of bulk losartan potassium, consisting of six 25 mg batches and 29 100 mg batches.
The Teva announcement, which lists the 44 drugs recalled, indicates that losartan potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy and nephropathy in patients with type 2 diabetes.
It added that the recalled batches had been sold exclusively to Golden State Medical Supply in Camarillo, California, and that Golden State was packing this product in bulk under its own label and distributing it in retail bottles of 30, 90 and 1,000 bottles. tablets.
Patients taking losartan potassium tablets are advised to continue taking their medication and to contact their pharmacist, doctor or health care provider for advice on alternative therapy. The immediate risk of harm to the patient's health will probably be higher if the drug is stopped abruptly without further treatment, he noted.
To date, Teva has stated that it has not received any reports of adverse events related to the recalled batches.
He added that no other potassium-based Teva losartan finished pharmaceutical product had been identified in the United States containing higher APIs than the interim specification levels set for the NMBA.
Teva Pharmaeceuticals USA, which holds the Major Pharmaceuticals label, was one of the first companies to issue a recall on an IPA in July due to the presence of a nitrosamine impurity.
He recalled valsartan-based products of 80 and 160 milligrams after the discovery of NDMA in the active pharmaceutical ingredient manufactured by the Chinese company Zhejiang Huahai Pharmaceuticals.
The presence of NDMA had been described as unexpected at the time, and the FDA believed that NDMA was linked to changes in the way the active substance was manufactured. He pointed out that certain levels of impurity could be present in products containing valsartan for four years.
The current FDA alert indicates that manufacturers should contact staff in the event of a drug shortage when their losartan tests indicate NMBA levels above the acceptable temporary intake limit of 0.96 ppm.
The FDA will determine, on a case-by-case basis, whether lots containing NMBAs greater than 0.96 ppm should be released for distribution.
The FDA website contains lists of recalled products. In addition, consumers can check if the FDA tests on their ARB-containing medications are not associated with any boosters have been completed and if no impurities have been found or are incomplete, but the product remains ". acceptable for distribution and for the use of the patient. "
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