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 5,678 bags of Dexmedetomidine 400 mcg in NS 100 mL due to a lack of sterility assurance. The affected products were distributed in North Carolina.
CMC Enterprise Pharmacy is recalling CeFAZolin 1 GM products in North Carolina due to a lack of sterility assurance.
CMC Enterprise Pharmacy is recalling 3,690 bags of Oxytocin 30 units in NS 500 mL due to a lack of sterility assurance. The product was distributed in North Carolina.
CMC Enterprise Pharmacy is recalling 532 bags of Vancomycin 1000 mg in NS 250 mL due to a lack of sterility assurance. The affected lots were distributed in North Carolina.
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.
CMC Enterprise Pharmacy is recalling 2,162 bags of Magnesium Sulfate 1 GM in NS 50 mL due to a lack of sterility assurance. The affected products were distributed in North Carolina.
CMC Enterprise Pharmacy is recalling 15 syringes of CefTRIAXone 1 GM due to a lack of sterility assurance. The affected lots were 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 1,783 bags of Nifedipine 25 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 110 bags of DelNido Cardioplegia in North Carolina due to a lack of sterility assurance.
CMC Enterprise Pharmacy is recalling 87 bags of Heparin Pork 30,000 Units in NS 1000 mL due to a lack of sterility assurance. The product was distributed in North Carolina.
CMC Enterprise Pharmacy is recalling 1,233 bags of Clindamycin 900 mg in NS 50 mL 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 715 bags of Vancomycin 1500 mg in NS 250 mL due to a lack of sterility assurance. The product was distributed in North Carolina.
CMC Enterprise Pharmacy is recalling 3,007 bags of Magnesium Sulfate 4 GM in NS 50 mL due to a lack of sterility assurance. The affected lots were distributed in North Carolina.
CMC Enterprise Pharmacy is recalling 60 syringes of Chlorothiazide 100 mg due to a lack of sterility assurance. The product was distributed in North Carolina.
CMC Enterprise Pharmacy is recalling 475 cefazolin syringes distributed in North Carolina because they lack sterility assurance.
CMC Enterprise Pharmacy is recalling 40 syringes of Lidocaine 1% - Sodium Bicarb 8.4% 10:1 for intradermal use 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 specific lots of CeFAZolin 2 GM in bags and syringes due to a lack of sterility assurance. The products were distributed in North Carolina.
CMC Enterprise Pharmacy is recalling 6,746 bags of Magnesium Sulfate 2 GM in NS 50 mL due to a lack of sterility assurance. The affected products were distributed in North Carolina.
CMC Enterprise Pharmacy is recalling Lidocaine 1% - Sodium Bicarbonate 8.4% syringes 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 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 737 bags of Vancomycin 1250 mg in NS 250 mL due to a lack of sterility assurance. The product was distributed in North Carolina.