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

    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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    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Sentara TPN Products Recalled Due to Lack of Sterility Assurance

    Sentara Infusion Services is recalling 26 bags of Total Parenteral Nutrition (TPN) solutions distributed nationwide because the manufacturer cannot assure the products maintain sterility. Patients receiving these products should contact their healthcare provider.

    Product
    TPN (a) 100GM/AA, 285GM/DEX, (b)55GM/LIP 2300ML, (c)55GM/AA 285GM/DEX 50GM/LIP1800ML, (d)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (e) 55GM DEX:285GM 1800ML, Rx Only, use with Curlin pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300…
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    0 states
  • HighFDA (Drugs)··2023-02-22

    Ampicillin/Sulbactam antibiotic injection recalled due to sterility concerns

    Sentara Infusion Services is recalling Ampicillin/Sulbactam 3GM intravenous bags due to lack of sterility assurance. The affected product was dispensed nationwide to home infusion patients.

    Product
    Ampicillin/Sulbactam 3GM IN NS 100ML, 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)…
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    0 states
  • HighFDA (Drugs)··2023-02-22

    Hydromorphone Infusion Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling Hydromorphone injectable solutions due to lack of sterility assurance. The recall affects 37 bags distributed nationwide.

    Product
    HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 60ML, 100ML, 250ML; pain, Rx only, used with a Curlin pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA…
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    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

    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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    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Ethanol 70% Syringes Recalled Due to Lack of Sterility Assurance

    Sentara Infusion Services is recalling 17 units of ETHANOL 70% 0.5ML syringes distributed nationwide due to lack of sterility assurance. The syringes may not meet required sterility standards for safe injection.

    Product
    ETHANOL 70% 0.5ML SYRINGE, Cathcare, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Levothyroxine Injectable Syringes Recalled Due to Lack of Sterility Assurance

    Sentara Infusion Services is recalling levothyroxine injectable syringes dispensed nationwide due to lack of sterility assurance. Patients should contact their healthcare provider if they received this product.

    Product
    LEVOTHYROXINE 25MCG IN NS 1.25ML SYRINGE, Thyroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Ondansetron 8mg Injectable Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling ondansetron 8mg injectable doses due to lack of sterility assurance. The medication was dispensed to patients nationwide with a beyond use date of December 29-30, 2022.

    Product
    ONDANSETRON 8MG IN NS 100ML, 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

    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…
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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

    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
    Category
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    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
  • HighFDA (Drugs)··2023-02-22

    Dobutamine Injectable Medication Recalled Due to Lack of Sterility Assurance

    Dobutamine injectable medication distributed by Sentara Infusion Services has been recalled due to lack of sterility assurance. If you received this medication, contact your healthcare provider for guidance.

    Product
    DOBUTAMINE, (a) 1080MG IN D5W 270ML, (b) 760MG IN D5W 190ML, ionotrop, used with a home pump, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
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    0 states
  • HighFDA (Drugs)··2023-02-22

    Hydrocortisone Sterile Injection Syringes Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling Hydrocortisone sterile injection syringes nationwide due to lack of sterility assurance. Patients who received affected syringes should contact their physician immediately.

    Product
    HYDROCORTISONE 9a) 2MG IN NS 0.2ML SYRINGE, 9MG IN NS 2ML SYRINGE, steroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 00009-0011-04
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    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

    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

    Fluconazole 200mg injection recalled due to sterility concerns

    Sentara Infusion Services is recalling Fluconazole 200mg injectable solution due to lack of sterility assurance. The recall affects 13 bags distributed nationwide to patients.

    Product
    FLUCONAZOLE 200MG NS 100ML, antifungal, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Meropenem Injectable Antibiotic Recalled Due to Lack of Sterility Assurance

    Sentara Infusion Services is recalling 91 bags of meropenem injectable antibiotic due to lack of sterility assurance. The product was dispensed nationwide to patients.

    Product
    MEROPENEM (a) 1000MG IN NS 250ML, (b) 2GM IN NS 100ML, (c) 500mg IN NS 125ML, antibiotic, Rx Only, use with 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

    Vancomycin Intravenous Solution Recalled Due to Sterility Assurance Issue

    Sentara Infusion Services is recalling Vancomycin 700 MG and 1000 MG intravenous solution formulations due to lack of sterility assurance. Eighteen bags were distributed nationwide.

    Product
    VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, use with home 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

    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
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    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    Cefoxitin injectable bags recalled nationwide for sterility assurance failure

    Cefoxitin injectable antibiotic (1GM and 2GM) prepared by Sentara Infusion Services is being recalled nationwide due to lack of sterility assurance. Affected patients should contact their pharmacy immediately.

    Product
    CEFOXITIN (a) 1GM IN NS 50ML,(b) 2GM IN NS 100ML, 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

    Vitamin K Injectable Syringes Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling Vitamin K (Phytonadione) 2.5mg injectable syringes distributed nationwide due to lack of sterility assurance. Patients should contact their healthcare provider.

    Product
    VITAMIN K(PHYTONADIONE) 2.5MG(0.25ML) SYRINGE, Rx only, 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