# FDA recall D-0761-2022

> **Pfizer Inc.** · Class II · drug recall initiated 2022-03-21.

## 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    .

## Reason for recall

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0761-2022
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-03-21
- **Report date:** 2022-04-13
- **Termination date:** 2024-08-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New York, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0761-2022

## Citation

> AI Analytics. FDA recall D-0761-2022. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0761-2022. Source: US FDA. Licensed CC0.

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