Pfizer is voluntarily recalling 5 a lot of Accupril (Quinapril HCI) resulting from unacceptable ranges of a nitrosamine, N-nitroso-quinapril, a possible carcinogen, the corporate introduced.
The Accupril recall comes one month after Pfizer recalled six a lot of Accuretic (Quinapril HCI/hydrochlorathiazide) tablets for a similar downside.
Accupril is indicated for the remedy of hypertension and administration of coronary heart failure when added to standard remedy, together with diuretics and/or digitalis.
To this point, Pfizer just isn’t conscious of any experiences of antagonistic occasions associated to the Accupril recall and the corporate believes the profit/danger profile stays optimistic primarily based on at the moment obtainable information.
“Though long-term ingestion of N-nitroso-quinapril could also be related to a possible elevated most cancers danger in people, there isn’t any instant danger to sufferers taking this treatment,” the corporate mentioned April 22 in a information launch.
Sufferers at the moment taking the recalled merchandise are requested to seek the advice of with their physician about various remedy choices.
The recalled Accupril tablets have been bought in 90-count bottles distributed nationwide to wholesalers and distributors in america and Puerto Rico from December 2019 to April 2022.
Nationwide drug codes (NDC), lot numbers and expiration dates are listed within the firm announcement posted on the Meals and Drug Administration’s web site.
Sufferers who’re taking this product ought to seek the advice of with their healthcare supplier or pharmacy to find out if they’ve the affected product. These with the affected tablets ought to contact claims administration agency Sedgwick by cellphone at 888-345-0481 Monday by Friday from 8 AM to five PM ET for directions on the way to return the product and procure reimbursement.
Healthcare suppliers with questions concerning the recall can contact Pfizer by phone at 800-438-1985, possibility 3, Monday by Friday from 8 AM to 9 PM ET.
Adversarial reactions or high quality issues associated to this recall needs to be reported to the FDA’s MedWatch program.
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