FDA (Drugs) recall action 85138
The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
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.
The Harvard Drug Group is recalling Quetiapine Fumarate Extended-Release Tablets because they were packaged with the wrong package insert.
The Harvard Drug Group is recalling Quetiapine Fumarate Extended-Release Tablets because they were packaged with the wrong package insert.
The Harvard Drug Group is recalling Quetiapine Fumarate Extended-Release Tablets because they were packaged with the wrong package insert.
The Harvard Drug Group is recalling 330 cartons of Quetiapine Fumarate Extended-Release Tablets because they were packaged with the wrong package insert.