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 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
Category
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
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
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
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
FDA recalls Milrinone injectable medication due to lack of sterility assurance
Sentara Infusion Services recalls 83 bags of Milrinone injectable medication nationwide due to lack of sterility assurance. Patients should contact their healthcare provider immediately.
Product
Milrinone (a) 104MG IN 0.45% NS 130ML,(b) 108MG IN 0.45% NS 135ML, (c) 120MG IN 0.45% NS 150ML, (d) 136MG IN 0.45% NS 170ML, (e) 144MG IN 0.45% NS 180ML, (f) 160MG IN 0.45% NS 200ML, (g) 168MG IN 0.45% NS 210ML, (h) 192MG IN 0.45% NS 240ML, (i) 44MG IN 0.45% NS 55 ML, (j) 52MG IN
Category
Distribution
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
Category
Distribution
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,
Category
Distribution
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
Category
Distribution
0 states
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,
Category
Distribution
0 states
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
Category
Distribution
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 ;
Category
Distribution
0 states
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
Category
Distribution
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 23
Category
Distribution
0 states
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
Category
Distribution
0 states
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,
Category
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, Chesapeak
Category
Distribution
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
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
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
Category
Distribution
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
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
Category
Distribution
0 states