Accuretic Blood Pressure Tablets Recalled for Excess Chemical Impurity
Pfizer is recalling Accuretic blood pressure tablets due to manufacturing deviations that resulted in N-nitroso chemical impurities exceeding safe intake limits. Patients should contact their pharmacist or physician.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with confirmed N-nitroso chemical impurities exceeding acceptable daily intake limits, representing risk-of-harm from known carcinogenic substances. No illnesses or injuries reported, placing this at Score 3 per the rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
Pfizer Inc. is recalling Accuretic (quinapril HCl/hydrochlorothiazide) 20 mg/25 mg tablets distributed nationwide due to manufacturing quality deviations.
Testing identified N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurities in lot ET6974 (expiring 02/2023) that exceeded the FDA's acceptable daily intake limits. These are known chemical contaminants that can pose health risks if the medication is continued.
The recall affects 265 bottles of the impacted lot. Patients taking Accuretic from this lot should contact their pharmacist or physician immediately for guidance on whether their medication is affected and what steps to take next.
The recalled product
- Product
- Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0223-23.
- Manufacturer
- Pfizer Inc.
- Affected units
- 265
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot ET6974
- Exp. 02/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Pfizer Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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