FDA (Drugs) recall action 61948
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.
Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.
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.
Bayer is recalling 119,412 cartons of Midol Complete because the blister strip label does not match the carton regarding the maximum daily dose.
Bayer Healthcare is recalling 48,528 cartons of Midol Complete because the maximum daily dose stated on the blister strip does not match the carton label.