FDA (Drugs) recall action 84860
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.
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
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 141 bottles of Caduet tablets because defective bottle rims may have allowed moisture to enter, potentially compromising the medication.
Pfizer is recalling 128 bottles of Caduet (amlodipine and atorvastatin) because defective bottle rims may have caused inadequate foil sealing, potentially compromising moisture protection.