FDA (Drugs) recall action 90229
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.
Strides Pharma Inc. is recalling Losartan Potassium 50 mg tablets distributed nationwide due to AZIDO impurity levels exceeding acceptable FDA manufacturing standards.
Strides Pharma Inc. is recalling Losartan Potassium 100 mg tablets nationwide due to CGMP deviations with AZIDO impurity levels above acceptable limits. Patients should contact their healthcare provider to verify if they are affected.
Strides Pharma is recalling approximately 200,407 bottles of Losartan Potassium 25 mg tablets nationwide due to AZIDO impurity levels exceeding acceptable manufacturing limits.