Multi-event December 2022 FDA Recall Drug by Sentara Infusion Services

This Multi-event Class II drug recall was voluntarily initiated by Sentara Infusion Services on December 27, 2022 for the product Drug. The FDA reported the reason for recall as lack of sterility assurance. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

Recall Number: D-0296-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
37 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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 23320, NDC# 00409-2634-50

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 24-31, 2022

Recall Number: D-0321-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
24 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 25-31, 2022

Recall Number: D-0281-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
3 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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,

Batch or Lot Expiration Information

Lot# Beyond Use date December 30, 2022

Recall Number: D-0280-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
71 bags total

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use Date December 24-31, 2022

Recall Number: D-0317-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
2 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
TOBRAMYCIN 660MG IN NS 66ML, antibiotic, Rx Only, use with homepump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,

Batch or Lot Expiration Information

Lot# Beyond Use Date, ecember 24, 2022

Recall Number: D-0311-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
31 syringes

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 29, 2022

Recall Number: D-0284-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
2

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
D5 NS 2300ML, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 26, 2022

Recall Number: D-0306-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
30 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 24-29, 2022

Recall Number: D-0318-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
26 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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, Chesapeake, VA 23320

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 24-3 , 2022

Recall Number: D-0312-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
15 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
ONDANSETRON 8MG IN NS 100ML, antimetic, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 29-30, 2022

Recall Number: D-0283-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
72 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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,

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 24-31, 2022

Recall Number: D-0288-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
1 bag

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
Dextrose 10% 720ML, TPN, Rx only, use with a home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 28, 2022

Recall Number: D-0300-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
25 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 24-31, 2022

Recall Number: D-0277-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
7 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
CASPOFUNGIN 50MG IN NS 100ML, used with a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 30-31, 2023

Recall Number: D-0289-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
15 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
Diphenhydramine 18mg in 3.6ML NS SYRINGE, antihistamine, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 29, 2022

Recall Number: D-0319-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
111 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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 ; 255GM/DEX ; 50GM/LIP 3500 ml, (i) 90GM/AA ; 255GMDEX 3500 ml, (j) TPN AA 100GM DEX: 320GM LIP: 50GM 2400ML, (k) TPN AA 30GM DEX: 145GM 1210ML, (l) TPN AA 30GM DEX: 145GM LIP: 35GM 1210ML, (m)TPN AA 42GM DEX: 432GM 2070ML, (n) TPN AA 50GM DEX: 130GM 2500ML, (o) TPN AA 55GM DEX:180GM 1000ML, (p) TPN AA 70GM DEX:290GM 2100ML, (q) TPN AA 70GM DEX:290GM 2500ML, (r) TPN AA 80GM DEX:200GM 1900ML, (s) TPN AA 80GM DEX:200GM LIP:38GM 1900ML, (t) TPN AA 30GM ; DEX 82GM ; IN 890 ml, (u) TPN AA 30GM ; DEX 82GM ; LIP 18GM IN 890 ml, Rx Only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 24-31, 2022

Recall Number: D-0305-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
27 syringes

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
Methylprednisolone 12MG IN NS 1.2ML SYRINGE, steroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 29-31, 2022

Recall Number: D-0286-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
17 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 25-30, 2022

Recall Number: D-0309-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
5 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 25-29, 2022

Recall Number: D-0316-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
11 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 24- 30, 2022

Recall Number: D-0303-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
91 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 24-31, 2022

Recall Number: D-0314-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
8 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 25-31, 2022

Recall Number: D-0272-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
114 bags total

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use date December 24 - December 31, 2022

Recall Number: D-0324-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
1 bag

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
VITAMIN K(PHYTONADIONE) 2.5MG(0.25ML) SYRINGE, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,

Batch or Lot Expiration Information

Lot# Beyond Use DateL December 29, 2022

Recall Number: D-0307-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
83 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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 0.45% NS 65ML, (k) 56MG IN 0.45% NS 70ML, (l) 68MG IN 0.45% NS 85ML, (m) 84MG IN 0.45% NS 105ML, (n) 88MG IN 0.45% NS 110ML, (o) 92MG IN 0.45% NS 115ML, (p) 96MG IN 0.45% NS 120ML, ionotrop, Rx Only, use with a Curlin or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 24-31, 2022

Recall Number: D-0294-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
5 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 24-29, 2022

Recall Number: D-0274-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
19 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
AMPICILLIN 12GM IN NS 600M, used with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,

Batch or Lot Expiration Information

Lot# Beyond Use date: December 25 - December 29, 2022

Recall Number: D-0323-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
18 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 28-31, 2022

Recall Number: D-0291-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
22 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 24-31, 2022

Recall Number: D-0279-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
8 syringes

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
CEFAZOLIN 5mg/mL/HEPARIN 100unit/ml 1.5ML SYR, antibiotic, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 29-31, 2022

Recall Number: D-0313-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
14 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
PANTOPRAZOLE 30MG IN NS 7.5ML, SYRINGE, antimetic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 29, 2022

Recall Number: D-0293-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
13 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
FLUCONAZOLE 200MG NS 100ML, antifungal, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 2-31, 2022

Recall Number: D-0308-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
11 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 24-31, 2022

Recall Number: D-0304-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
19 syringes

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 28-29, 2022

Recall Number: D-0310-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
16 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 25-31, 2022

Recall Number: D-0295-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
32 syringes

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 24-31, 2022

Recall Number: D-0320-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
31 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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: AA 60GM ; DEX 200GM ; LIP 30GM IN 1500 ml, Rx only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 24-31, 2022

Recall Number: D-0273-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
7 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
Amikacin 450MG IN NS 45ML, Antibiotic, used in a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300 Chesapeake, VA 23320,

Batch or Lot Expiration Information

Lot# Beyond Use date: December 28 - December 30, 2022

Recall Number: D-0302-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
7 syringes

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
LEVOTHYROXINE 25MCG IN NS 1.25ML SYRINGE, Thyroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 29, 2022

Recall Number: D-0299-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
14 syringes

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
KYTRIL 350MCG IN 3.5ML NS SYRINGE, antimetic, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 29, 2022

Recall Number: D-0276-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
20 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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,

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 25-December 30, 2022

Recall Number: D-0297-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
7 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 25-30, 2022

Recall Number: D-0275-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
14 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
AMPICILLIN 8GM IN NS 400ML, antibiotic, used with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 25-December 30, 2022

Recall Number: D-0282-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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,

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 25-30, 2022

Recall Number: D-0301-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
14 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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,

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 24-31, 2022

Recall Number: D-0287-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
17 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 24-31, 2022

Recall Number: D-0315-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
78 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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, Chesapeake, VA 23320

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 25-31, 2022

Recall Number: D-0322-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
155 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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 300, Chesapeake, VA 23320

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 24-31, 2022

Recall Number: D-0292-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
17 syringes

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
ETHANOL 70% 0.5ML SYRINGE, Cathcare, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 25-31, 2022

Recall Number: D-0298-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
7 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
INTRALIPID 18GM, TPN, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 29-30, 2022

Recall Number: D-0278-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
111 bags total 21 syringes total

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use By: December 25-31, 2022

Recall Number: D-0285-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
8 bags

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
D5W1/2NS W/ 77MEQ OF SOD ACETATE 1000ML, Hydration, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 29-31, 2022

Recall Number: D-0290-2023

Reason for Recall
Lack of sterility assurance
Initiated
12-27-2022
Reported
02-22-2023
Quantity
4

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sentara Infusion Services
Dispensed to Patients Nationwide.
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

Batch or Lot Expiration Information

Lot# Beyond Use Date: December 29, 2022