Recalls / Class II
Class IID-0761-2022
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 .
- Affected lot / code info
- Lot FG5381; Exp. 08/2024
Why it was recalled
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Recalling firm
- Firm
- Pfizer Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, New York, New York 10017-5703
Distribution
- Quantity
- 195 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2022-03-21
- FDA classified
- 2022-04-06
- Posted by FDA
- 2022-04-13
- Terminated
- 2024-08-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0761-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.