FDA (Drugs) recall action 81910
The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
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.
Prinston Pharmaceutical Inc is recalling Irbesartan and Hydrochlorothiazide tablets because FDA labs found the impurity NDEA above acceptable levels.
Prinston Pharmaceutical Inc. is recalling Irbesartan and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA) above acceptable levels.
Prinston Pharmaceutical Inc. is recalling Irbesartan 300 mg tablets because FDA testing found N-nitrosodimethylamine (NDEA) levels above the interim acceptable daily intake.
Prinston Pharmaceutical Inc. is recalling Irbesartan and Hydrochlorothiazide tablets because FDA testing found N-nitrosodimethylamine (NDEA) above the acceptable daily intake level.
Prinston Pharmaceutical Inc. is recalling Irbesartan and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable limits.