Indian generics maker Aurobindo is to pull another product from the shelves.
According to the FDA, the company’s US subsidiary, Aurobindo Pharma USA, has issued a voluntary recall of two lots of the heart drug Quinapril. The recall was issued for a “nitrosamine drug substance related impurity” above the proposed limit.
Nitrosamines, a common organic chemical in water or food, can increase the risk of cancer if people are exposed to them for an extended period. The FDA reported that Aurobindo Pharma USA had received no reports of adverse reactions related to the recall.
The FDA advises patients taking Quinapril to consult with a physician or health care provider to determine whether they should continue taking the drug or if an alternative should be found.
The FDA announcement said:
“Qualanex, on behalf of Aurobindo Pharma USA, Inc., will notify its distributors and customers by telephone and in writing to immediately discontinue distribution of the specific lots being recalled and notify their sub-accounts” ,
Aurobindo also organizes the return of all recalled products.
Any general questions regarding the recall should contact this number: 1-888-504-2014, and any adverse reactions may be reported to the FDA’s MedWatch Adverse Event Reporting program.
Nitrosamines have been successful in removing products from the shelves. Last year, Pfizer’s anti-smoking drug Chantix was recalled at a high rate due to high levels of nitrosamines. It also came as the FDA recently conducted a major revision to its guidelines for drug manufacturing facilities, noting that they now had to document nitrosamines as well as nitrosating agents, nitrates and azides.
For Aurobindo, the company recalled several products this year, including moxifloxacin ophthalmic solution — an antibiotic used to treat eye infections like bacterial conjunctivitis. In January, Aurobindo voluntarily recalled a batch of polymyxin B for injection after a hair was found in a vial of the batch.
The company, which has undergone multiple FDA inspections, also closed its Dayton, New Jersey, site earlier this year, eliminating 99 jobs in the process.
The story has been updated to reflect that two batches of the drug have been recalled.