FDA (Drugs) recall action 80307
The FDA (Drugs) publishes a recall like this one as 38 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 38 pages.
Lack of Assurance of Sterility: Potential leakage of bags.
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.
Avella of Deer Valley is recalling 220 bags of Midazolam 0.5mg/mL due to potential bag leakage and lack of assurance of sterility.
Avella of Deer Valley, Inc. is recalling 275 single-dose hydromorphone syringes nationwide due to a lack of assurance of sterility caused by potential bag leakage.
Avella of Deer Valley, Inc. is recalling 15 cassettes of fentanyl and bupivacaine due to potential bag leakage and lack of sterility assurance.
Avella of Deer Valley is recalling 40 Ropivacaine OnQ pumps due to potential bag leakage that compromises sterility.
Avella of Deer Valley, Inc. is recalling 660 bags of Hydromorphone injection due to potential leakage that compromises sterility.
Avella of Deer Valley is recalling 420 bags of Epinephrine 4 mg in 5% Dextrose due to potential leakage that compromises sterility.
Avella of Deer Valley, Inc. is recalling 25 bags of Magnesium Sulfate in Sodium Chloride due to potential leakage and lack of sterility assurance.
Avella of Deer Valley is recalling 10,500 ephedrine sulfate syringes nationwide due to potential bag leakage and lack of sterility assurance.
Avella of Deer Valley, Inc. is recalling 700 bags of Epinephrine (USP) 4 mg due to potential leakage that compromises sterility.
Avella of Deer Valley is recalling 1,352 bags of Vancomycin 1.25gm in D5W 250 mL due to potential leakage that compromises sterility.
Avella of Deer Valley is recalling 100 fentanyl and ropivacaine cassettes due to potential bag leakage and lack of sterility assurance.
Avella of Deer Valley is recalling 120 fentanyl syringes due to potential bag leakage and lack of assurance of sterility.
Avella of Deer Valley, Inc. is recalling 740 single-dose Morphine 150 mg syringes due to a lack of assurance of sterility caused by potential bag leakage.