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.

26–50 of 53

  • HighFDA (Drugs)··2023-02-22

    Metronidazole injectable antibiotic recalled due to sterility concerns

    Sentara Infusion Services is recalling 30 bags of Metronidazole 500mg injectable antibiotic distributed nationwide due to lack of sterility assurance. Patients using the product should contact their healthcare provider.

    Product
    METRONIDAZOLE 500MG 100ML, antibiotic, Rx Only, use with a home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    FDA Recalls TPN Nutrition Bags Due to Sterility Assurance Failure

    Sentara Infusion Services recalls 24 bags of TPN (Total Parenteral Nutrition) distributed nationwide due to lack of sterility assurance. The recall affects prescription intravenous nutrition products.

    Product
    TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (c) TPN: AA 80GM ; DEX 320GM ; LIP 50GM IN 2300 ml, Rx only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Ertapenem Injectable Antibiotic Bags Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling 22 bags of Ertapenem (Invanz) injectable antibiotic due to lack of sterility assurance. The product was dispensed nationwide to patients receiving home infusion therapy.

    Product
    Ertapenem (Invanz) 1GM NS 100ML, antibiotic, use with home pump, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Cefepime injectable antibiotic bags recalled due to sterility concerns

    Sentara Infusion Services is recalling 71 bags of Cefepime injectable antibiotic due to lack of sterility assurance. Patients who received affected doses should consult their healthcare provider.

    Product
    CEFEPIME, (a) 2GM IN NS 100ML (b)8GM IN NS 400ML (c) 12GM IN NS 600ML, used with a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Levaquin 750MG Injectable Recalled Due to Lack of Sterility Assurance

    Sentara Infusion Services is recalling 14 bags of Levaquin 750MG injectable antibiotic dispensed nationwide due to lack of sterility assurance. The product was distributed to patients for home infusion pump use.

    Product
    Levaquin 750MG IN D5W 150ML, antibiotic, Rx Only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Ampicillin IV Infusion Bags Recalled for Lack of Sterility Assurance

    Sentara Home Infusion Pharmacy Services is recalling 14 bags of Ampicillin 8GM in NS 400ML due to lack of sterility assurance. The affected batches were distributed nationwide to patients.

    Product
    AMPICILLIN 8GM IN NS 400ML, antibiotic, used with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Tobramycin 660mg Injectable Antibiotic Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling Tobramycin 660mg injectable antibiotic used for home infusion therapy due to lack of sterility assurance. Two bags were dispensed to patients nationwide.

    Product
    TOBRAMYCIN 660MG IN NS 66ML, antibiotic, Rx Only, use with homepump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Cefazolin Antibiotic Injections Recalled Due to Sterility Assurance Failure

    Sentara Infusion Services is recalling Cefazolin antibiotic injections due to lack of sterility assurance. The recall affects 111 bags and 21 syringes distributed nationwide.

    Product
    CEFAZOLIN (a) 12GM IN NS 600ML, (b) 2GM IN NS 100ML, (c) 2GM/20ML SW SYRINGE, (d) 3GM IN NS 150ML, antibiotic, used with a curlin, home or no pump assigned. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
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    0 states
  • HighFDA (Drugs)··2023-02-22

    Nafcillin Antibiotic Infusion Recalled Due to Sterility Assurance Failure

    Sentara Infusion Services is recalling 16 bags of nafcillin antibiotic infusion nationwide due to lack of sterility assurance. Patients should contact their healthcare provider immediately.

    Product
    NAFCILLIN 24GM IN NS 1200ML, antibiotic, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Nalbuphine Syringes Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling 31 nalbuphine syringes (1.5mg and 2.5mg) dispensed nationwide due to lack of sterility assurance. Patients should contact their healthcare provider.

    Product
    NALBUPHINE (a) 1.5MG IN 1.5ML NS, (b) 2.5MG IN 2.5ML NS, SYRINGE, pain, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Methylprednisolone steroid injections recalled for lack of sterility assurance

    Sentara Infusion Services is recalling 27 syringes of Methylprednisolone steroid due to lack of sterility assurance. The product was distributed nationwide to patients with a beyond-use date of December 29-31, 2022.

    Product
    Methylprednisolone 12MG IN NS 1.2ML SYRINGE, steroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Piperacillin/Tazobactam Injectable Antibiotic Recalled Due to Lack of Sterility Assurance

    Sentara Infusion Services is recalling Piperacillin/Tazobactam antibiotic injections due to lack of sterility assurance. The 78-unit recall affects patients nationwide.

    Product
    PIPERACILLIN / TAZOBACTAM (a) 4.5GM IN NS 100 ML, (b)18GM IN NS 267M, (c) 27GM IN NS 400ML, (d) 3.375 GM IN NS 50ML, (e) 36 GM IN NS 533 ML, antibiotic, Rx only, use with a Curlin or home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, C
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Injectable Cefazolin-Heparin Syringes Recalled Nationwide for Lack of Sterility Assurance

    Sentara Infusion Services is recalling compounded Cefazolin/Heparin injectable syringes due to lack of sterility assurance. Eight syringes with a December 2022 beyond-use date are affected.

    Product
    CEFAZOLIN 5mg/mL/HEPARIN 100unit/ml 1.5ML SYR, antibiotic, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    FDA Recalls D5 NS Injectable Solution for Lack of Sterility Assurance

    Sentara Infusion Services is recalling D5 NS 2300mL, an injectable dextrose-saline solution, due to lack of sterility assurance. The product was dispensed to patients nationwide.

    Product
    D5 NS 2300ML, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Ceftriaxone injectable antibiotic recalled for lack of sterility assurance

    Sentara Infusion Services recalled 72 bags of ceftriaxone injectable antibiotic due to lack of sterility assurance. The affected product was distributed nationwide with a beyond-use date of December 24–31, 2022.

    Product
    CEFTRIAXONE (a) 2GM in NS 100ml, (b) 4GM IN NS 200ML, Antibiotic, used with a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    KYTRIL Antiemetic Syringes Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling KYTRIL 350mcg syringes distributed nationwide due to lack of sterility assurance. Patients who received affected units should contact their healthcare provider.

    Product
    KYTRIL 350MCG IN 3.5ML NS SYRINGE, antimetic, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Dextrose 10% TPN Solution Recalled Due to Sterility Assurance Concerns

    Sentara Infusion Services is recalling Dextrose 10% 720ML TPN injectable solutions nationwide due to lack of sterility assurance. Patients using this product should contact their healthcare provider.

    Product
    Dextrose 10% 720ML, TPN, Rx only, use 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

    Intravenous hydration solution recalled for lack of sterility assurance

    Sentara Infusion Services is recalling D5W1/2NS W/ 77MEQ OF SOD ACETATE 1000ML intravenous hydration solution due to lack of sterility assurance. Eight bags were dispensed to patients nationwide.

    Product
    D5W1/2NS W/ 77MEQ OF SOD ACETATE 1000ML, Hydration, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Sodium Chloride Diluent Recalled Due to Sterility Assurance Failure

    Sentara Infusion Services is recalling Sodium Chloride 0.9% solution dispensed to patients nationwide due to lack of sterility assurance. The product was used as a diluent in home infusion therapy with Curlin or Sapphire pumps.

    Product
    Sodium Chloride 0.9 % (a) 100ML (MAGNESIUM) (b) 69.3ML, (c) 71.4ML, (d) 77.7ML, (e) 130ML, (f) 210ML, (g) 190ML, (h) 220ML: diluent, Rx Only, use with Curlin or Sapphire pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
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    0 states
  • HighFDA (Drugs)··2023-02-22

    Lactated Ringers IV Solution Recalled for Sterility Assurance Failure

    Sentara Infusion Services is recalling Lactated Ringers IV solutions (NDC 00338-0117-03) due to lack of sterility assurance. The recall affects 25 bags dispensed nationwide with a Beyond Use Date of December 24-31, 2022.

    Product
    Lactated Ringers packaged in volume of 1000ML, 2500ML, 3000 ML, 3600 ML, 500ML (NDC 00338-0117-03)hydration, Rx Only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
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    0 states
  • HighFDA (Drugs)··2023-02-22

    Caspofungin Injectable Medication Recalled for Sterility Assurance Issues

    Sentara Infusion Services is recalling Caspofungin 50mg injectable bags dispensed nationwide due to lack of sterility assurance. Patients should consult their healthcare provider.

    Product
    CASPOFUNGIN 50MG IN NS 100ML, used with a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Mycamine 100mg Intravenous Preparation Recalled for Sterility Assurance Deficiency

    Sentara Infusion Services recalled Mycamine 100mg intravenous solution nationwide due to lack of sterility assurance. Patients should contact their healthcare provider.

    Product
    MYCAMINE 100MG IN NS 100ML, antifungal, Rx Only, use with a homepump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Vancomycin Injectable Bags Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling 155 bags of vancomycin injectable solution in multiple concentrations due to lack of sterility assurance. The product was dispensed nationwide for home infusion use.

    Product
    Vancomycin (a) 1.25GM IN NS 250ML, (b) 1.5GM IN NS 300ML, (c) 1000MG IN NS 200ML (d) 2GM IN 400ML NS, (e) 900MG IN NS 180ML, (f) 500 MG NS 100ML, (g) 750 MG NS 150ML, antibiotic, Rx only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 3
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Ganciclovir Injectable Solution Recalled Due to Lack of Sterility Assurance

    Sentara Infusion Services is recalling Ganciclovir (Cytovene) injectable solutions due to lack of sterility assurance. The medication was dispensed to patients nationwide.

    Product
    GANCICLOVIR ( CYTOVENE) (a)1480MG IN NS 296ML, (b) 740 MG IN NS 336 ML, antiviral, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Ceftriaxone Injectable Antibiotic Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling Ceftriaxone antibiotic infusions nationwide because the manufacturer cannot assure the products meet sterility standards. Patients should contact their healthcare provider.

    Product
    CEFTRIAXONE (a) 1GM IN NS 50ML, (b)4GM IN NS 200ML, (c) 8GM IN NS 400ML, antibiotic, Rx only, used in a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Distribution
    0 states