FDA (Drugs) recall action 90064
The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Pfizer is recalling 2,079 bottles of Accupril (Quinapril HCl) 10 mg tablets due to N-nitrosoquinapril exceeding acceptable limits. The affected lot was distributed nationwide and in Puerto Rico.
Pfizer is recalling Accupril (Quinapril HCl) 20 mg tablets nationwide and in Puerto Rico due to N-nitrosoquinapril levels exceeding acceptable limits. Affected lots include DX8682 and DG1188.
Pfizer is recalling specific lots of Accupril (quinapril HCl) 40 mg tablets distributed nationwide and in Puerto Rico because the product contains N-nitrosoquinapril above acceptable limits, a manufacturing deviation.