Accuretic — Class II drug recall D-0754-2022
Terminated recall by Pfizer Inc., reported 2022-04-13, distributed nationwide. CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily int
| Recall number | D-0754-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2022-03-21 |
| Classified | 2022-04-06 |
| Reported by FDA | 2022-04-13 |
| Terminated | 2024-08-28 |
| Distributed | Nationwide (US) |
| Quantity | 53 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 00071-3112-23 |
| Lot numbers | FG5379 |
| Expiration dates | 2024-08 |
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.
Reason for recall
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0754-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.