FDA (Drugs) recall action 86530
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
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.
Marksans Pharma Limited is recalling Metformin Hydrochloride Extended Release tablets due to N-Nitrosodimethylamine (NDMA) impurity levels above acceptable intake limits.
Time-Cap Labs, Inc. is recalling Metformin Hydrochloride Extended-Release Tablets 500 mg because the FDA detected the impurity N-Nitrosodimethylamine (NDMA) above acceptable intake levels.