FDA (Drugs) recall action 92133
The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.
Labeling: Incorrect or Missing Package Insert
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.
Teva Pharmaceuticals USA Inc is recalling Fentanyl Buccal Tablets 800mcg due to incorrect or missing package inserts. The recall affects 3,032 units distributed nationwide.
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 100mcg due to incorrect or missing package inserts in affected cartons. Patients should verify proper labeling or contact their pharmacy.
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 400mcg due to incorrect or missing package inserts in affected cartons distributed nationwide. No illnesses have been reported.
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 600mcg due to incorrect or missing package inserts in 1,908 units distributed nationwide across multiple lot numbers.
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets (200mcg) due to missing or incorrect package inserts. Patients should contact their healthcare provider if they have affected product.