The Recall Desk
HighFDA (Drugs)·D-0756-2022·Announced 2022-04-13

Accuretic Tablets Recalled Due to Excess N-Nitroso Impurity

Pfizer is recalling Accuretic (quinapril/hydrochlorothiazide) tablets nationwide due to N-nitroso impurities exceeding acceptable daily intake limits. The impurity resulted from a manufacturing deviation.

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 N-nitroso chemical impurities exceeding acceptable daily intake limits. Per the rubric, this represents a risk-of-harm product without reported illness or injury, meeting the criterion for High (3) severity.

Plain-English summary

Pfizer Inc. is recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg, due to N-nitroso impurities exceeding acceptable daily intake limits. The recall involves 1,364 bottles distributed nationwide.

The impurities, N-nitroso-quinapril and N-nitroso-hydrochlorothiazide, resulted from a manufacturing deviation from good manufacturing practices (CGMP). Affected lots are EA6665 and CN0640, both with an expiration date of April 2022.

Consumers should contact their healthcare provider or pharmacist if they have obtained this medication. Healthcare providers can determine if a patient's medication is affected and provide appropriate guidance.

The recalled product

Product
Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tablets bottles, Rx Only Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0220-23.
Manufacturer
Pfizer Inc.
Category
Drug
Hazard
  • n-nitroso-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 (3)

  • Lot EA6665
  • Exp Date 04/2022
  • Lot CN0640

Distribution

Distributed nationwide across the United States.

Related recalls

Same category