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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
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TOPIC: Lots of ACCUPRIL® (Quinapril HCl) by Pfizer: Recall - Due to N-Nitroso-Quinapril Content
AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy, Cardiology
ISSUE: Pfizer is recalling five lots of Accupril (Quinapril HCl) tablets distributed by Pfizer due to the presence of a nitrosamine, Nnitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.
To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND:
Accupril is indicated for the treatment of hypertension, to lower blood pressure. Accupril is also indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis.
RECOMMENDATIONS:
- Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product.
- Patients with the affected product should contact Sedgwick.
- Healthcare Professionals with questions regarding this recall can contact Pfizer.
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Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
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Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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