The Recall Desk
HighFDA (Drugs)·D-0755-2022·Announced 2022-04-13

Pfizer Accuretic Blood Pressure Tablets Recalled for Chemical Impurity

Pfizer is recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets nationwide due to unacceptable levels of N-nitroso chemical impurities from manufacturing deviations. The affected lot includes 160 bottles.

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: This FDA Class II recall involves chemical impurities (N-nitroso compounds) above acceptable daily intake limits, representing a risk-of-harm product. No illnesses or injuries have been reported, placing it in the High category per the severity rubric.

Plain-English summary

Pfizer Inc. is recalling Accuretic (quinapril HCl/hydrochlorothiazide) 10 mg/12.5 mg tablets nationwide. The recall affects 160 bottles from lot EA6686 with an expiration date of April 2022. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations that resulted in N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurities at levels above the acceptable daily intake limit.

N-nitroso compounds pose potential health risks. While no illnesses or injuries have been reported to date, patients who received tablets from the affected lot may have been exposed to these impurities at higher than normally acceptable levels.

Patients who believe they may have tablets from lot EA6686 should contact their healthcare provider or pharmacist immediately. They can verify the lot number on their medication bottle. Healthcare providers can advise on appropriate next steps.

The recalled product

Product
Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0222-23
Manufacturer
Pfizer Inc.
Category
Drug
Hazard
  • chemical-impurity
  • carcinogen-risk

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 EA6686
  • Exp. 04/2022

Distribution

Distributed nationwide across the United States.

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