Aurobindo Pharma recalled two lots of the medications Quinapril and Hydrochlorothiazide for impurity on Tuesday, as they were found to contain N-nitroso-quinapril.
The recalled lots were QE2021005-A and QE202101-A of quinapril and hydrochlorothiazide tablets USP 20mg/12.5mg. Each has an expiration date of January 2023 and is contained in 90-count bottles.
The tablets are “pink, scored, round shaped, biconvex, and film-coated. On the scored side, they are debossed with ‘D,’ and on the other side, they are debossed with ’19’.
Aurobindo Pharma released a statement explaining that N-nitroso-quinapril, a nitrosamine, can “increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.”
Despite recalling the drug, Aurobindo assured patients that “nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables. Everyone is exposed to some level of nitrosamines.”
The news of the recall comes a month after a recall of Aurobindo’s tranexamic acid injection for the “presence of particulate matter.” A piece of metal was found “in a vial,” according to the Food and Drug Administration (FDA).
The Indian pharmaceutical company has faced FDA scrutiny before. In January 2022, the FDA issued a warning letter to Aurobindo Pharmaceutical for “significant deviations from current good manufacturing practices (CGMP)” for its “controls for manufacturing, processing, packing, or holding.”
The letter suggested that Aurobindo had deviated from CGMP as early as 2019. At the time, Aurobindo claimed it would remedy such deviations.
Aurobindo encourages patients to contact their doctor with questions regarding whether they should continue taking either Quinapril or Hydrochlorothiazide until they find a replacement.
For many who experience hypertension, blood pressure medication helps maintain stable blood pressure and stave off cardiac events such as stroke or heart attack.
GoodRX Health advised that “suddenly stopping blood pressure medications may cause serious side effects or withdrawal symptoms.” Therefore, it is best to consult a doctor before stopping the medication altogether.
As of yet, no incidences of medical injury have been reported.
If you take one or more of these medications and have any questions or wish to report an adverse event, call 1-866-850-2876 (option 2). The phone line is open 24 hours per day, seven days per week.
Alternatively, you may also report the incident by email at [email protected].
