FDA (Drugs) recall action 82620
The FDA (Drugs) publishes a recall like this one as 32 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 32 pages.
Lack of sterility assurance.
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.
CMC Enterprise Pharmacy is recalling 215 bags of Phenylephrine 40 mg in 0.9% Sodium Chloride due to a lack of sterility assurance. The product was distributed in North Carolina.
CMC Enterprise Pharmacy is recalling 532 bags of Vancomycin 2000 mg in 0.9% Sodium Chloride due to a lack of sterility assurance.
CMC Enterprise Pharmacy is recalling 196 bags of Magnesium Sulfate 6 GM in NS 50 mL due to a lack of sterility assurance. The product was distributed in North Carolina.
CMC Enterprise Pharmacy is recalling 2,567 bags of Norepinephrine 16 mg in NS 250 mL due to a lack of sterility assurance. The affected products were distributed in North Carolina.
CMC Enterprise Pharmacy is recalling 100 bags of Sodium Bicarbonate 150 mEq in D5W 1000 mL due to lack of sterility assurance.
CMC Enterprise Pharmacy is recalling 110 bags of DelNido Cardioplegia in North Carolina due to a lack of sterility assurance.
CMC Enterprise Pharmacy is recalling 1,475 bags of Diltiazem 250 mg in NS 250 mL due to a lack of sterility assurance. The product was distributed in North Carolina.