Trio of Indian drugmakers issue recalls tied to impurity, labeling issues
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 recall covers twice-a-day dosages of the blood pressure med in 60 mg, 90 mg, and 120 mg strengths, plus 90 mg and 120 mg bottles of the drug's extended-release format. The suspect diltiazem lots were manufactured by Glenmark in India for multiple different customers.
The company also recalled 69,967 bottles of the delayed-release anti-anxiety drug duloxetine. The recall of the drugs, which were distributed throughout the U.S., was triggered by the presence of N-nitroso-duloxetine impurities. The product purge concerns 20 mg, 30 mg and 60 mg dosages. 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.
