FDA (Drugs) recall action 90200
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- AZIDO Impurity levels observed to be above acceptable limits .
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.
Direct Rx is recalling Losartan Potassium and Hydrochlorothiazide tablets due to azido impurity levels above acceptable limits resulting from manufacturing deviations. Patients should consult their healthcare provider regarding their medication.
Direct Rx is recalling batches of Losartan Potassium/Hydrochlorothiazide tablets due to CGMP deviations with elevated AZIDO impurity levels. The affected product was distributed in Florida.
Direct Rx recalled Losartan Potassium and Hydrochlorothiazide tablets due to azido impurity levels exceeding acceptable limits. The recall affects 11 bottles distributed in Florida.