FDA (Drugs) recall action 98614
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
CGMP Deviations: use of an unapproved raw material
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 is recalling three lots of Clonidine Transdermal System, USP, 0.3 mg/day, citing CGMP deviations involving the use of an unapproved raw material. 113,943 cartons are affected.
Teva is recalling two lots of Clonidine Transdermal System, USP, 0.2 mg/day, citing CGMP deviations involving the use of an unapproved raw material. 62,136 cartons are affected.
Teva is recalling two lots of Clonidine Transdermal System, USP, 0.1 mg/day, citing CGMP deviations involving the use of an unapproved raw material. 124,054 cartons are affected.