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.

1–25 of 53

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
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0 states
HighFDA (Drugs)··2023-02-22
Methadone Syringes Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling methadone syringes due to lack of sterility assurance. The affected product was dispensed to patients nationwide.
Product
METHADONE (a) 2.5MG IN 5ML NS SYRINGE, (b) 4MG IN 5ML NS SYRINGE, pain, 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
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
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0 states
HighFDA (Drugs)··2023-02-22
INTRALIPID 18GM Parenteral Nutrition Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling 7 bags of INTRALIPID 18GM, a parenteral nutrition solution, due to lack of sterility assurance. The product was dispensed to patients nationwide.
Product
INTRALIPID 18GM, TPN, Rx Only, use with a 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
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,
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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
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0 states
HighFDA (Drugs)··2023-02-22
Antibiotic Injectable Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling an antibiotic injectable medication due to lack of sterility assurance. Seven bags were dispensed to patients nationwide with a Beyond Use Date of December 2022.
Product
IMIPENEM/CILASTATIN 2000MG IN NS 400ML, antibiotic, Rx Only, use with a Curlin Pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 63323-0322-25
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HighFDA (Drugs)··2023-02-22
Amikacin Injectable Antibiotic Lacks Sterility Assurance, Nationwide Recall
Sentara Infusion Services is recalling 7 bags of Amikacin 450MG injectable antibiotic due to lack of sterility assurance. The product was dispensed nationwide to patients receiving IV infusions.
Product
Amikacin 450MG IN NS 45ML, Antibiotic, used in a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300 Chesapeake, VA 23320,
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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…
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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
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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
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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
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0 states
HighFDA (Drugs)··2023-02-22
FDA Recalls 0.9% Sodium Chloride Solution for Lack of Sterility Assurance
Sentara Infusion Services is recalling 114 bags of 0.9% Sodium Chloride intravenous solution due to lack of sterility assurance. The product was distributed nationwide with Beyond Use dates of December 24–31, 2022.
Product
0.9% Sodium Chloride, used as a diluent or hydration, packaged volume of (a)1000ML (b)2000ML (c) 720ML, used with Curlin pump, no pump or gravity. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
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HighFDA (Drugs)··2023-02-22
Morphine Sulfate Intravenous Solutions Recalled Due to Sterility Assurance Failure
Sentara Infusion Services is recalling Morphine Sulfate intravenous infusion solutions (1 mg/mL and 5 mg/mL) distributed nationwide due to lack of sterility assurance. The products may not be sterile, creating a potential risk of infection.
Product
MORPHINE Sulfate (a) 1MG/ML IN NS 350ML, (b) 5MG/ML IN NS 200ML, pain, 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
FDA Class II: TPN solution bags lack sterility assurance
Sentara Infusion Services is recalling 111 bags of TPN (Total Parenteral Nutrition) solution due to lack of sterility assurance. Products were dispensed nationwide to patients.
Product
TPN 107gm/AA, 200gm/DEX, 50gm/LIP 2250mL, (b) 108GM/AA, 330GM/DEX 3000ML, (c) 108GM/AA, 330GM/DEX, 60GM/LIP 3000ML, (d) 37GM/AA, 160GM/DEX 1450ML, (e) 37GM/AA, 160GM/DEX, 25GM/LIP 1450ML, (f) 74-100GM OF PROTEIN B4197 74 Gm, (g) 75GM/AA, 200GM/DEX, 43GM/LIP 2500ML, (h) 90GM/AA…
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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
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HighFDA (Drugs)··2023-02-22
Penicillin Intravenous Antibiotic Recalled Over Lack of Sterility Assurance
Sentara Infusion Services is recalling eight bags of intravenous penicillin antibiotic due to lack of sterility assurance. The product was dispensed to patients nationwide.
Product
PENICILLIN (a) 40MU IN D5W 400ML(CONTINUOUS), (b) 40U IN D5W 400ML(CONTINUOUS), (c) 48MU IN D5W 480ML, antibiotic, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
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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,
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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
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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
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HighFDA (Drugs)··2023-02-22
FDA Recalls Pantoprazole Injectable Syringes for Sterility Assurance Failure
Sentara Infusion Services is recalling Pantoprazole 30mg intravenous syringes due to lack of sterility assurance. The product was dispensed to patients nationwide.
Product
PANTOPRAZOLE 30MG IN NS 7.5ML, SYRINGE, antimetic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
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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,
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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,
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HighFDA (Drugs)··2023-02-22
Daptomycin Antibiotic Injectable Syringes Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling Daptomycin pre-filled syringes distributed nationwide due to lack of sterility assurance. Patients using this antibiotic should contact their healthcare provider immediately.
Product
DAPTOMYCIN (a)360MG in NS 18ML syringe (b)580MG IN NS 29ML syringe(c) 630MG IN NS 31.5ML used with a home pump; antibiotic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
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HighFDA (Drugs)··2023-02-22
Diphenhydramine 18mg Injectable Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling Diphenhydramine 18mg syringes distributed nationwide due to lack of sterility assurance. The 15-bag recall affects injectable antihistamine products that may pose an infection risk if used.
Product
Diphenhydramine 18mg in 3.6ML NS SYRINGE, antihistamine, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
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