FDA (Drugs) recall action 72746
The FDA (Drugs) publishes a recall like this one as 34 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 34 pages.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
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.
Sentara Enterprises is recalling specific lots of Morphine 10mg/ml in NS infusion bags because the sterility of the product cannot be guaranteed.
Sentara Enterprises is recalling 28 bags of Nafcillin 2GM in NS due to a lack of assurance of sterility. The affected product was distributed in Virginia and North Carolina.
Sentara Enterprises is recalling specific lots of Sodium Chloride Homepumps because the sterility of the product cannot be guaranteed.
Sentara Enterprises is recalling Tobramycin 120MG Homepumps because the sterility of the product cannot be guaranteed. The affected lots were compounded in September 2015.
Sentara Enterprises is recalling specific lots of Intralipid fat emulsion because the product's sterility cannot be guaranteed. The affected bags were distributed in Virginia and North Carolina.
Sentara Enterprises is recalling specific lots of Gentamicin Homepumps because the sterility of the product cannot be guaranteed. The affected bags were distributed in Virginia and North Carolina.
Sentara Enterprises is recalling 7 bags of compounded Cancidas (caspofungin acetate) because the sterility of the product cannot be guaranteed.
Sentara Enterprises is recalling 7 bags of Dextrose-5% Lactated Ringers because the sterility of the product cannot be guaranteed.
Sentara Enterprises is recalling specific lots of Potassium Chloride in D 5 1/2NS home infusion bags because sterility cannot be guaranteed.
Sentara Enterprises is recalling specific lots of Lactated Ringers because product sterility cannot be guaranteed. The affected bags were distributed in Virginia and North Carolina.
Sentara Enterprises is recalling specific lots of Cefazolin because the sterility of the product cannot be guaranteed. The affected products were distributed in Virginia and North Carolina.
Sentara Enterprises is recalling 9 bags of Ampicillin/Sulbactam 12GM in NS due to a lack of assurance of sterility. The affected products were distributed in Virginia and North Carolina.
Sentara Enterprises is recalling 6 bags of Clindamycin 120mg in NS Homepumps because product sterility cannot be guaranteed. The affected lots were compounded in September 2015 and distributed in Virginia and North Carolina.
Sentara Enterprises is recalling specific lots of Hydromorphone HCL because the sterility of the product cannot be guaranteed.
Sentara Enterprises is recalling specific lots of Milrinone in 0.45% NS homepumps because the sterility of the product cannot be guaranteed.
Sentara Enterprises is recalling specific lots of ZOSYN (piperacillin/tazobactam) homepumps because product sterility cannot be guaranteed. The affected products were distributed in Virginia and North Carolina.
Sentara Enterprises is recalling Parenteral Amino Acid Infusion 10% bags because product sterility cannot be guaranteed. The recall affects specific lots compounded in September 2015.
Sentara Enterprises is recalling Meropenem in NS Homepumps because product sterility cannot be guaranteed. The recall affects 192 bags distributed in Virginia and North Carolina.
Sentara Enterprises is recalling 77 bags of Ondansetron HCL 8mg Homepumps because the product's sterility cannot be guaranteed. The affected lots were distributed in Virginia and North Carolina.
Sentara Enterprises is recalling specific lots of CUBICIN (daptomycin) in NS syringes and homepumps because the sterility of the product cannot be guaranteed.
Sentara Enterprises is recalling specific lots of Invanz (ertapenem) injection homepumps because product sterility cannot be guaranteed. The affected products were distributed in Virginia and North Carolina.
Sentara Enterprises is recalling 10 bags of Mycamine (micafungin sodium) 150mg because product sterility cannot be guaranteed.
Sentara Enterprises is recalling specific lots of Ceftriaxone in NS Homepumps because product sterility cannot be guaranteed. The recall affects 82 bags distributed in Virginia and North Carolina.
Sentara Enterprises is recalling specific lots of Dextrose-NaCl (D5-1/2NS) in Homepumps because product sterility cannot be guaranteed.
Sentara Enterprises is recalling 12 bags of AZACTAM (aztreonam) 2GM in NS because product sterility cannot be guaranteed. The affected lots were compounded in September 2015 and distributed in Virginia and North Carolina.