Recalls / Class II
Class IID-0872-2022
Product
Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
- Affected lot / code info
- Lot: DR9639 Exp. MAR 31 2023
Why it was recalled
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Recalling firm
- Firm
- Pfizer Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 2079 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2022-04-22
- FDA classified
- 2022-05-16
- Posted by FDA
- 2022-05-25
- Terminated
- 2023-10-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0872-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.