The Recall Desk

FDA (Drugs) recall action 91466

Sentara Infusion Services recalled 53 products on 2023-02-22

The FDA (Drugs) publishes a recall like this one as 53 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 53 pages.

Products
53
Announced
2023-02-22
Critical
0
Units
1,406

Why these products were recalled

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.

51–53 of 53

  • HighFDA (Drugs)··2023-02-22

    Daptomycin Injectable Antibiotic Recalled Due to Sterility Assurance Failure

    Sentara Infusion Services is recalling daptomycin injectable antibiotic bags due to lack of sterility assurance. The 17 affected bags were dispensed nationwide and pose a potential infection risk.

    Product
    DAPTOMYCIN (a) 400MG IN NS 20ML, (b) 550MG IN NS 27.5ML, antibiotic, Rx only, used with a home pump. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    TPN parenteral nutrition bags recalled due to lack of sterility

    Sentara Infusion Services is recalling 31 TPN bags due to lack of sterility assurance. The recalled bags with Beyond Use Dates December 24–31, 2022, were dispensed nationwide to patients.

    Product
    TPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (b)90GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (c) TPN AA: 100GM DEX: 105GM 2700ML, (d) TPN AA: 100GM DEX: 105GM LIP: 45GM 2700ML, (e) TPN: AA100GM ; DEX185GM ; LIP50GM IN 1500ML, (f) TPN: AA 150GM ; DEX 220GM ; LIP 45GM IN 2400 ml, (g) TPN
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Ampicillin Injectable Solution Recalled Due to Lack of Sterility Assurance

    Sentara Infusion Services is recalling Ampicillin 12GM in NS 600M injectable solution due to lack of sterility assurance. The affected product was dispensed nationwide; patients should contact their healthcare provider.

    Product
    AMPICILLIN 12GM IN NS 600M, used with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Distribution
    0 states