FDA (Drugs) recall action 78332
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.
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
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 specific lots of diphenoxylate hydrochloride and atropine sulfate tablets because weight variations caused some tablets to be sub-potent or super-potent.
Pfizer is recalling 1,972 bottles of Zoloft 25 mg tablets because weight variations caused some tablets to be sub or super potent.