All recalled products had unacceptable levels of nitrosamines
Three pharmaceutical manufacturers have recalled batches of the blood pressure drug quinapril this year for exceeding safe levels of nitrosamines. Luprin Pharmaceuticals, Aurobindo Pharma USA, and Pfizer all announced quinapril recalls for levels of nitrosamines that exceeded established safety limits. All recalls were made voluntarily by the drug company, and they all involved the nitrosamine N-Nitroso-Quinapril.
Although they are considered to be an impurity in drug products, nitrosamines are organic compounds that are often present in meat, vegetables, dairy products, and water. They can cause cancer through exposure to elevated levels over a long period of time.
Pfizer recalls Accupril tablets
In April 2022, Pfizer voluntarily recalled several lots of its Accupril (Quinopril HCl) for the presence of a nitrosamine in a concentration that was above the level of Acceptable Daily Intake (ADI). Accupril has a 30-year safety record in treating hypertension and as an adjunctive therapy for the management of heart failure. In its recall announcement Pfizer stated that it believes that, even with higher nitrosamine levels, the treatment benefits of the drug far outweigh its risks.
Aurobindo Pharma recalls Quinapril and Hydrochlorothiazide tablets
On October 24, 2022, Aurobindo Pharma USA announced a recall of batches of its Quinapril and Hydrochlorothiazide tablets due to a Nitrosamine Drug Substance Related Impurity (NDSRI) above their established interim limit. The tablets are a fixed-combination medication that contains quinapril hydrochloride, an angiotensin-converting enzyme (ACE) inhibitor, and a diuretic, hydrochlorothiazide.
Lupin Pharmaceuticals recalls Quinapril tablets
And most recently, in December 2022 Lupin Pharmaceuticals recalled four lots of its blood pressure medication Quinapril tablets due to elevated levels of nitrosamines. Its recall announcement mentions the benefits of taking a hypertension, or blood pressure medication – healthy blood pressure levels reduce the risk of cardiovascular issues like strokes and heart attacks. Lupin stopped marketing the drug in September 2022.
What to do if you have been prescribed a recalled medication
Nitrosamine impurities have become somewhat common in the past few years. And On its webpage “What to Know and Do About Possible Nitrosamines in Your Medication” FDA provides information for individuals who may be taking a recalled blood pressure medication. First, do not stop taking the drug. The short-term risk of taking a medication with elevated nitrosamine levels is likely outweighed by the benefit of taking the medicine. Second, call your pharmacist. Your pharmacy professional can identify whether your medication is affected. And if it is, the pharmacist can provide a replacement.
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