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 500 syringes of ephedrine sulfate due to potential bag leakage and lack of sterility assurance.
Avella of Deer Valley is recalling 100 fentanyl syringes due to potential bag leakage and lack of sterility assurance.
Avella of Deer Valley is recalling 120 bags of Phenylephrine 20 mg IV solution due to potential bag leakage and lack of sterility assurance.
Avella of Deer Valley, Inc. is recalling 20 bags of 0.2% Ropivacaine infusion cassettes due to potential leakage that compromises sterility.
Avella of Deer Valley is recalling 240 bags of Heparin 25,000 Units in 5% Dextrose due to potential bag leakage and lack of sterility assurance.
Avella of Deer Valley is recalling 40 bags of Phenylephrine 10 mg due to potential leakage that compromises sterility. The product was distributed nationwide.
Avella of Deer Valley, Inc. is recalling 850 single-dose norepinephrine syringes nationwide due to potential bag leakage that may compromise sterility.
Avella of Deer Valley is recalling 1,290 bags of Norepinephrine Bitartrate 4 mg due to potential leakage and lack of sterility assurance.
Avella of Deer Valley, Inc. is recalling 40 bags of Heparin 1,000 Units in NS 250mL due to potential leakage that compromises sterility.
Avella of Deer Valley is recalling 900 bags of Heparin 12,500 Units in 5% Dextrose due to potential bag leakage and lack of sterility assurance.
Avella of Deer Valley is recalling 175 bags of Magnesium Sulfate in Sodium Chloride due to potential bag leakage and lack of sterility assurance.
Avella of Deer Valley is recalling 4,280 bags of Norepinephrine 8 mg due to potential bag leakage and lack of assurance of sterility.
Avella of Deer Valley, Inc. is recalling 225 syringes of ePHEDrine Sulfate due to potential bag leakage and lack of sterility assurance.
Avella of Deer Valley is recalling 200 bags of Phenylephrine 40 mg due to potential leakage that compromises sterility.
Avella of Deer Valley is recalling 100 bags of Magnesium Sulfate in Sodium Chloride due to potential bag leakage and lack of sterility assurance.
Avella of Deer Valley is recalling 480 single-dose hydromorphone syringes due to potential bag leakage and lack of sterility assurance.
Avella of Deer Valley is recalling 2,280 bags of Norepinephrine Bitartrate in 5% Dextrose due to potential bag leakage and lack of sterility assurance.
Avella of Deer Valley, Inc. is recalling 1,500 bags of Morphine 1 mg/mL due to potential bag leakage and lack of assurance of sterility.
Avella of Deer Valley, Inc. is recalling 2,500 bags of ceFAZolin 2 gm in NS 100mL due to potential bag leakage that compromises sterility.
Avella of Deer Valley, Inc. is recalling 1,860 bags of Midazolam 1 mg/mL due to potential bag leakage and lack of assurance of sterility.
Avella of Deer Valley, Inc. is recalling 110 syringes of Midazolam 1 mg/mL due to a lack of assurance of sterility and potential bag leakage.
Avella of Deer Valley, Inc. is recalling 520 bags of NORepiNEPHrine 16 injection due to potential bag leakage and lack of assurance of sterility.
Avella of Deer Valley is recalling 130 bags of Morphine 1 mg/mL due to potential bag leakage and lack of assurance of sterility.
Avella of Deer Valley, Inc. is recalling specific lots of Midazolam 1 mg/mL syringes due to a lack of assurance of sterility and potential bag leakage.
Avella of Deer Valley is recalling specific lots of ePHEDrine 50mg syringes because bags may leak, compromising sterility.