FDA (Drugs) recall action 93867
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.
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder 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.
Teva Pharmaceuticals is recalling Nortrel 7/7/7 oral contraceptive tablets due to a manufacturing defect: discolored blue tablets mixed with white inert tablets. This could cause confusion about which tablets to take in the triphasic regimen.
Teva Pharmaceuticals is recalling 12,916 cartons of Nortrel oral contraceptive tablets nationwide due to discolored inert remainder tablets that may cause confusion. Affected lot: #100042978, expiration 7/31/2024.