Recalls / Class II
Class IID-0756-2022
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.
- Affected lot / code info
- Lot EA6665, Exp Date 04/2022, Lot CN0640, Exp Date 04/2022
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
- 1364 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-0756-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.