Accuretic tablets recalled for N-nitroso impurities exceeding safe limits
Pfizer is recalling 195 bottles of Accuretic blood pressure tablets nationwide due to N-nitroso impurities exceeding acceptable daily intake limits. No illnesses have been reported.
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: This is an FDA Class II recall involving impurities (N-nitroso compounds) that exceed the established acceptable daily intake limit, representing a known potential health risk. Although no illnesses or injuries have been reported, the presence of impurities above safety thresholds qualifies as a high-risk situation under the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Pfizer Inc. is recalling 195 bottles of Accuretic (quinapril HCl/hydrochlorothiazide) 20 mg/12.5 mg tablets (Lot FG5381, expiration 08/2024) distributed nationwide. The recall was initiated due to manufacturing deviations that resulted in N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurities in the product that exceed the acceptable daily intake limit.
N-nitroso compounds are contaminants that can form during the manufacturing process. FDA has set acceptable daily intake limits for these impurities based on safety data. This recall addresses product that contains levels above those established safety thresholds.
Patients currently taking this medication should contact their healthcare provider or pharmacist. Because Accuretic is a prescription blood pressure medication, patients are already under medical supervision. Healthcare providers can determine whether affected patients should continue their current medication, switch to an alternative, or take other appropriate action. No illnesses related to this recall have been reported.
The recalled product
- Product
- Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY. NY 10017, Made in Germany, NDC 0071-5212-23 .
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Antihypertensive
- Hazard
- Affected units
- 195
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 FG5381
- Exp. 08/2024
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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