FDA (Drugs) recall action 97974
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: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) 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.
Cipla USA is recalling 12,576 bottles of Cinacalcet Hydrochloride Tablets, 90 mg, over the presence of N-nitroso-cinacalcet above the acceptable daily intake limits.
Cipla USA is recalling 63,504 bottles of Cinacalcet Hydrochloride Tablets, 30 mg, over the presence of N-nitroso-cinacalcet above the acceptable daily intake limits.
Chetak New York is recalling Deep-brand frozen garlic cloves after the product tested positive for Salmonella. The FDA has classified the action as Class I.