FDA (Drugs) recall action 89916
The FDA (Drugs) publishes a recall like this one as 6 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 6 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.
Lupin Pharmaceuticals is recalling Losartan Potassium and Hydrochlorothiazide tablets distributed nationwide due to elevated AZIDO impurity levels detected during manufacturing quality control.
Lupin Pharmaceuticals recalls Losartan Potassium and Hydrochlorothiazide tablets nationwide due to manufacturing deviations that resulted in AZIDO impurity levels above acceptable limits.
Lupin Pharmaceuticals is recalling 1.47 million bottles of Losartan Potassium Tablets due to chemical impurities exceeding acceptable limits. The affected batches were distributed nationwide.
Lupin Pharmaceuticals is recalling Losartan Potassium and Hydrochlorothiazide 100 mg/25 mg tablets nationwide due to AZIDO impurity levels above acceptable limits. Patients should consult their healthcare provider about their medication.
Lupin Pharmaceuticals recalls Losartan Potassium tablets for CGMP deviations with AZIDO impurity above limits. The recall affects 657,336 bottles distributed nationwide; no illnesses reported.
Lupin Pharmaceuticals is recalling Losartan Potassium Tablets 100 mg nationwide due to AZIDO impurity levels exceeding acceptable manufacturing limits. Approximately 1,247,067 bottles were affected.