FDA (Drugs) recall action 90383
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.
PD-Rx Pharmaceuticals is recalling Losartan Potassium 100 mg tablets due to AZIDO impurity levels above acceptable limits detected during manufacturing. Approximately 1,320 bottles were distributed nationwide.
PD-Rx Pharmaceuticals recalls Losartan Potassium Tablets (25 mg, 90-tablet bottles) due to Current Good Manufacturing Practice deviations. Specific lot numbers contain AZIDO impurity levels above acceptable limits.
PD-Rx Pharmaceuticals recalled Losartan Potassium 50 mg tablets nationwide due to AZIDO impurity levels exceeding acceptable manufacturing limits. The recall affects 687 bottles across multiple lots.