FDA (Drugs) recall action 86600
The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
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 1,683 bottles of Metformin Hydrochloride Extended Release 500 mg because of NDMA impurity levels above acceptable limits.
PD-Rx Pharmaceuticals is recalling 125 bottles of Metformin Hydrochloride Extended Release tablets because of NDMA impurity levels above acceptable limits.