Pfizer recalls Accuretic blood pressure tablets for impurities exceeding acceptable limits
Pfizer is recalling 53 bottles of Accuretic blood pressure tablets nationwide due to manufacturing impurities that exceed FDA acceptable daily intake limits. The affected lot is FG5379, expiring August 2024.
What this means for you
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 identified impurities above acceptable daily intake limits. No reported hospitalizations, injuries, or illnesses in the source. Per the rubric, Class II recalls without reported harm score at 'High' (3), as risk-of-harm is present but unmanifested.
Plain-English summary
Pfizer Inc. is recalling Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg. The recall involves 53 bottles with lot number FG5379, expiration date August 2024, distributed nationwide.
The recall was initiated due to manufacturing deviations identified during quality control. The tablets contain impurities (N-nitroso-quinapril and N-nitroso-hydrochlorothiazide) at levels that exceed the FDA's acceptable daily intake limits.
Patients taking this medication should contact their healthcare provider or pharmacist immediately regarding the recalled lot. Healthcare facilities and pharmacies are advised to cease dispensing the affected lot and to notify patients who may have received this medication.
The recalled product
- Product
- Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-3112-23.
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Antihypertensive
- Hazard
- nitrosamine-impurity
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 FG5379
- Exp. 08/2024
Distribution
Distributed nationwide across the United States.
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