Aurobindo Pharma’s US branch issues recall of two generic drugs – Endpoints News
The Indian generics manufacturer Aurobindo has to pull another product from the shelves.
According to the FDA, the company’s American branch, Aurobindo Pharma USA, has issued a voluntary recall of two products, the heart drug Quinapril and the “water pill” hydrochlorothiazide tablets in quantities of 20 and 12.5 mg. The recall was issued over a “Nitrosamine Drug Substance Related Impurity” above the proposed limit.
Nitrosamines, an organic chemical commonly found in water or foods, can increase the risk of cancer if people are exposed to them over a long period of time. The FDA reported that Aurobindo Pharma USA has not received any reports of adverse reactions related to the recall.
The FDA advises patients taking Quinapril to consult a doctor or health care professional about whether they should continue taking the drug or whether an alternative must be obtained.
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 to notify their sub-accounts,”
Aurobindo also arranges for the return of all recalled products as well.
All 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 managed to pull products off the shelves before. Last year, Pfizer’s anti-smoking drug Chantix was recalled at high speed over elevated levels of nitrosamines. This also came as the FDA had recently undertaken a major revision of its guidance for drug manufacturing facilities, noting that they must now document nitrosamines along with nitrosating agents, nitrates and azides.
For Aurobindo, the company has recalled several products this year, including moxifloxacin ophthalmic solution – an antibiotic used to treat eye infections such as bacterial conjunctivitis. In January, Aurobindo voluntarily recalled a lot of polymyxin B for injection after hair was found in a vial in the batch.
The company, which has been the subject of several FDA inspections, also shut down its Dayton, New Jersey site earlier this year, eliminating 99 jobs in the process.