Another recall for India's troubled drug manufacturer
Aurobindo Pharma USA, the subsidiary of India’s top 10 drug company Aurobindo, recalled two lots of a generic blood pressure medication on October 24. The recall was voluntary. It’s their second voluntary recall of blood press medicine in four years.
The drugs were found to be tainted and Aurobindo advised patients to consult their doctor if they have a prescription.
The recall was for two specific lots of Quinapril and Hydrochlorothiazide tablets of 20mg and 12.5mg, respectively. The generic medication is used to treat hypertension and lower blood pressure. The tablets are pink, scored, round, film-coated tablets with the letter ‘D’ on the scored side and the number ‘19’on other side.
The drugs had too much N-Nitroso-quinapril in the mix, a type of nitrosamine that is present as an impurity. Nitrosamines are organic compounds which can damage DNA by killing or depleting functional human cells that can cause organs to age faster. DNA damage is the primary cause of cancers. Nitrosamines are mostly commonly found in low levels in food, some drinking water, and in air pollution.
Pfizer ran into similar problems with nitrosamines in March and recalled its blood pressure medication Accuretic.
Aurobindo’s labs in India have been inspected by the FDA six times over the last two years.
Last year, FDA inspectors recommended regulatory and/or administrative actions after a visit at its Unit I lab in Doultabad. At another visit this year, the FDA found what would be considered minor infractions, which included matters related to equipment and record keeping.
But 2022 started off on the wrong foot for Aurobindo. The company was issued a Warning Letter on January 12 – essentially a D-grade from FDA inspectors which can lead to bans on product sales in the U.S. That letter did not lead to any restrictions on Aurobindo products entering the U.S. pharmaceuticals market.
The January 12 letter was also about the Doultabad lab, warning of “significant deviations from good manufacturing practices for active pharmaceutical ingredients”. Good manufacturing practices (GMP) is like an FDA crib sheet on how labs selling drugs to the U.S. should operate.
In a previous FDA meeting with Aurobindo held on July 29, 2019 at its Unit I lab, the FDA sounds its first current GMP deviations alarm in its first Aurobindo Warning Letter.
Aurobindo proposed specific remediation for these deviations in their response in 2019. But the FDA noted in their recent, January letter that “repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”
Aurobindo’s Unit I lab did a voluntary recall of another generic blood pressure drug, Irbesartan, in 2018. Aurobindo cited its own lackluster GMP on that one, adding that numerous batches were found to have too much N-Nitrosodimethylamine, a carcinogen impurity that was detected in the active ingredient.
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We are a group of doctors, patients, health care industry experts, and advocates fighting to ensure all generic medicines are safe, affordable, and always available. Unsafe generic drugs from foreign manufacturers in China and India have been sold in the U.S that have been contaminated with carcinogens and fake ingredients, fall apart when tested, and don’t work as they should. We are fighting back to ensure all generic medicines are safe, affordable, and always available. We want every American to be able to trust the generics they take—every pill, every vial, every time.
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