Federal regulators have confirmed that Aurobindo Pharma recalls their blood pressure medication due to the risk of cancer. The decision was unanimously made by the company as per reports. According to the U.S. Food and Drug Administration, the pharmaceutical giant will revoke two containers of hydrochlorothiazide and quinapril tablets due to nitrosamine levels. According to the FDA, nitrosamines can be found in foods and H2O, including dairy offerings, vegetables, and grilled meat.
Aurobindo Pharma USA is a division of the Indian pharmaceutical firm Aurobindo Pharma Ltd. and is headquartered in East Windsor, New Jersey. The parent company originated in India and spread across various nations across the globe within a span of 30-plus years. Their main product offerings include semi-synthetic penicillins, but it also has a strong presence in other important therapeutic areas like gastroenterology, neurosciences, cardiology, anantiretroviralsanti-diabetics, and antibiotics. Its subsidiary Aurobindo Pharma USA was considered one of the fastest-growing pharmaceutical companies in 2012. The company gives credit to its clientele for its success.
As per the statement released by the agency, it is assumed that everyone is somehow exposed to nitrosamines. If people are exposed to these contaminants at amounts above what is considered safe for a long time, they may increase their risk of developing cancer. As per the FDA, Aurobindo Pharma USA has not yet received any reports of unfavorable events connected to this recall.
Fixed-combination tablets containing quinapril and hydrochlorothiazide treat hypertension and reduce blood pressure. In May 2021, the company started sending the relevant batches, QE2021005-A and QE2021010-A, to clients all around the country.
The FDA described the medication as a “pink colored, round shaped, biconvex, film-coated tablets, debossed with ‘D’ on the scored side and ’19’ on the other side,”
The patients may have to take several precautionary measures before planning to return the prescription. The FDA has stated that patients should contact their doctors or healthcare hospitals about whether to keep taking their medication or pursue an alternative course of treatment.
Distributors and clients of Aurobindo Pharma USA will get phone calls from Qualanex, which manages recall-product withdrawal services, instructing them to stop selling the specific lots that are being recalled immediately and informing their subaccounts. All recalled goods will be returned to Qualanex by Aurobindo Pharma USA.
A news channel has reported another instance of product recall where Moxifloxacin ophthalmic solution, an antibiotic used to treat eye infections such as bacterial conjunctivitis was recalled by Aurobindo Pharma Ltd. A hair was discovered in a vial of polymyxin B for injection in January, leading Aurobindo to voluntarily recall the entire lot. The business, which has been the target of numerous FDA inspections, shut down its Dayton, New Jersey, location earlier this year, leading to delayering of staff.
