FDA (Drugs) recall action 98636
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.
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
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.
Fagron is recalling Vancomycin HCl 1.5 grams in 250 mL sodium chloride bags for lack of assurance of sterility and because a blue break-off part could detach from the administration port.
Fagron is recalling Vancomycin HCl 1.25 grams in 250 mL sodium chloride bags for lack of assurance of sterility and because a blue break-off part could detach from the administration port.
Fagron is recalling norepinephrine bitartrate 16 mg in 250 mL sodium chloride bags for lack of assurance of sterility and because a blue break-off part could detach from the administration port.
Fagron is recalling norepinephrine bitartrate 32 mg in 250 mL sodium chloride bags for lack of assurance of sterility and because a blue break-off part could detach from the administration port.
Fagron Sterile Services is recalling Vancomycin HCl 1 gram in 250 mL sodium chloride bags for lack of assurance of sterility and because a blue break-off part could detach from the administration port.