FDA (Drugs) recall action 74964
The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
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.
Lupin Limited is recalling Amlodipine Besylate tablets because they were manufactured using active pharmaceutical ingredients that failed specifications.
Lupin Limited is recalling Amlodipine Besylate tablets because they were manufactured using active pharmaceutical ingredients whose intermediates failed specifications.