Nebivolol hydrochloride

The North Carolina facility cited in the FDA's Form 483 produces inhalers and dermatology products. Aurobindo's manufacturing operations have once again landed the Indian drugmaker in hot water with the U.S. FDA.Aurobindo's subsidiary Aurolife Pharma received a Form 483 from the FDA outlining 11 observations at a U.S. production plant, the Indian drugmaker said in a filing late last week. The exact nature of the infractions remain unclear, as the FDA has not published the document.The regulatory rebuke follows an inspection at Aurolife's Raleigh, North Carolina, manufacturing facility that ran from March 24 through April 10, Aurobindo explained in a filing (PDF) Friday with the National Stock Exchange of India and BSE, formerly known as the Bombay Stock Exchange. The facility produces inhalers and dermatology products.In its filing, the company characterized the regulator's observations as “procedural in nature” and said that it will promptly submit a response to the FDA detailing corrective measures at the plant. “We do not expect this development to have any material impact on the current business operations or existing supplies from this facility,” Aurobindo said. Aurobindo is no stranger to FDA scrutiny. In late 2024, the company recalled more than 103,000 bottles of cinacalcet tablets thanks to unacceptable levels of the potential carcinogen N-nitroso Cinacalcet. The drug is used to treat hyperparathyroidism in patients with chronic kidney disease who are on dialysis.At the same time, the company also recalled an undisclosed amount of the high blood pressure drug nebivolol, also due to the presence of excess levels of a nitrosamine drug substance-related impurity. Meanwhile, last August, the FDA slammed Aurobindo’s Eugia manufacturing unit near Hyderabad, India, with a warning letter after the site had received an official action indicated (OAI) notice in May. An OAI designation is a sort of precursor to more formal reprimands from the FDA indicating that a facility risks running afoul of regulatory and administrative requirements and could pose a danger to public health.At the time of its warning letter in August, Eugia had been cited with four Form 483s at various facilities throughout India since late 2023. In December 2023, the FDA also issued a citation for a plant in New Jersey that Aurobindo said it planned to sell.

Indian drugmakers Aurobindo, Glenmark and Zydus have issued separate drug recalls linked to issues with impurities and labeling. Indian drugmakers Aurobindo, Glenmark and Zydus have issued separate sweeping drug recalls over issues pertaining to impurities and labeling.The product pulls were reported in a recent edition of the U.S. FDA's weekly enforcement report, which catalogs recalls after they've been properly classified by the regulator.In the case of Aurobindo, the company issued a recall of more than 100,000 bottles of cinacalcet at the 30 mg dose and more than 3,300 bottles at the 60 mg dose.  The company also recalled an undisclosed number of 90 mg bottles.The drug is used to treat hyperparathyroidism in patients with chronic kidney disease who are on dialysis.The recall for cinacalcet, which was manufactured in India, was attributed to the presence of N-nitroso Cinacalcet impurity levels that exceeded recommended limits set by the FDA. N-nitroso compounds are considered potentially carcinogenic. The drugs in question were distributed nationwide in the U.S., and the recall has been classified as Class II, which means there is a low chance of serious injuries or death. Aurobindo also recalled an undisclosed amount of nebivolol 2.5 mg tablets in 30-count bottles due to the presence of excess levels of the nitrosamine drug substance-related impurity N-Nitroso Nebivolol. The recall of nebivolol, which is used to treat high blood pressure, is also classified as Class II. The tablets were shipped out across the U.S., though Aurobindo didn’t specify where the products were manufactured.Glenmark Pharmaceuticals, for its part, issued voluntary recalls for 90,528 bottles of the high blood pressure drug diltiazem hydrochloride in tablet and extended-release forms due to unacceptable levels of another N-nitroso compound, N-nitroso-Desmethyl-Diltiazem.  The suspect diltiazem lots were manufactured by Glenmark in India for multiple different customers. As with the other recalls listed in the enforcement report, Glenmark’s medicine withdrawal falls under Class II.Meanwhile, Zydus Pharmaceuticals recalled 4,404 40 mg single-dose packets of the acid reflux treatment esomeprazole magnesium due to a labeling issue. The product, which was produced in India, was distributed nationwide in the U.S. The recall has been classified as Class III, which is the least severe of the FDA’s recall rankings. N-nitroso compounds, and in particular nitrosamines, crop up in countless products, including cured meats, beer and medicine. Some nitrosamines cause cancer in laboratory animals and may increase the risk of certain types of cancer in humans, according to the National Cancer Institute. Notably, the discovery of N-nitrosodimethylamine (NDMA) in Zantac led to mass product pulls and lawsuits over the popular heartburn med around the start of the decade. More recently, Dr. Reddy’s Laboratories in November said it was yanking 331,590 bottles of cinacalcet—the same drug covered in Aurobindo's recall—after uncovering traces of a nitrosamine-related impurity in certain batches of the product.