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Recall Observatory FDA recall evidence

Drug 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

D-0872-2022

April 22, 2022

Class II

Product summary

Firm
Pfizer Inc.
Event
Event 90064
Status
Terminated
Classification
Class II
Quantity
2079 bottles
Official record key
drug-enforcement:D-0872-2022

Official wording

Reason: CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.

Code information: Lot: DR9639 Exp. MAR 31 2023

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations