CLASS II Drug recall · Reported 22 Feb 2023 · FDA Enforcement Report

Daptomycin (a)360MG in NS syringe recalled by Sentara Infusion Services

Sentara Infusion Services is recalling Daptomycin (a)360MG in NS syringe (b)580MG IN NS syringe(c) 630MG IN NS used with a home, distributed nationwide in the US. The recall was initiated on 27 Dec 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBeyond Use Date: December 25-30, 2022

Quantity recalled17 bags

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0286-2023
FDA event ID: 91466
Recalling firm: Sentara Infusion Services, Chesapeake, VA
Classification: Class II
Status: Terminated
Recall initiated: 27 Dec 2022
FDA classified: 15 Feb 2023
Reported: 22 Feb 2023
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

27 Dec 2022	Recall initiated by company
15 Feb 2023	Classified by FDA	+50 days
22 Feb 2023	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of sterility assurance

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Dispensed to Patients Nationwide.

Nationwide

Questions about this recall

Why was it recalled?

Lack of sterility assurance

Which lots are affected?

Beyond Use Date: December 25-30, 2022

Where was it sold?

Dispensed to Patients Nationwide.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

52 other products · FDA event 91466

This product is part of a recall event; the main page for the event is Hydromorphone (a) 1MG/ML IN NS recalled by Sentara Infusion Services.

Reported	Class	Recall	Company	Reason	Where
22 Feb 2023	CLASS II	Hydromorphone (a) 1MG/ML IN NS recalled by Sentara Infusion Services	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Vancomycin (a)700 MG NS, (b) 1000MG IN NS, abtibiotic recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Metronidazole 500MG, antibiotic recalled by Sentara Infusion Services	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Imipenem/Cilastatin 2000MG IN NS, antibiotic recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	TPN (a) 95GM/AA, 385/DEX, 50GM/LIP recalled by Sentara Infusion Services	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	TPN (a) 100GM/AA, 285GM/DEX, (b)55GM/LIP recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Cefoxitin (a) 1GM IN NS,(b) 2GM IN NS, used with a home pump recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Ertapenem (Invanz) 1GM NS, antibiotic, use with home pump recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Levothyroxine 25MCG IN NS Syringe, Thyroid recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	TPN 107gm/AA, 200gm/DEX, 50gm/LIP, (b) 108GM/AA, 330GM/DEX recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Cefepime, (a) 2GM IN NS (b)8GM IN NS (c) 12GM IN NS recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Levaquin 750MG IN D5W, antibiotic recalled by Sentara Infusion Services	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Ampicillin 8GM IN NS, antibiotic, used with Curlin pump recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Meropenem (a) 1000MG IN NS, (b) 2GM IN NS, (c) 500mg IN NS recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Methadone (a) 2.5MG IN NS Syringe, (b) 4MG IN NS Syringe, pain recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Tobramycin 660MG IN NS, antibiotic recalled by Sentara Infusion Services	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Cefazolin (a) 12GM IN NS, (b) 2GM IN NS recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Nafcillin 24GM IN NS, antibiotic recalled by Sentara Infusion Services	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Hydrocortisone 9a) 2MG IN NS Syringe, 9MG IN NS Syringe, steroid recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Nalbuphine (a) 1.5MG IN NS, (b) 2.5MG IN NS, Syringe, pain recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Methylprednisolone 12MG IN NS Syringe, steroid recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Piperacillin / Tazobactam (a) 4.5GM IN NS recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Penicillin (a) 40MU IN D5W(Continuous) recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Ondansetron 8MG IN NS, antimetic recalled by Sentara Infusion Services	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Cefazolin 5mg/mL/Heparin/ml Syr, antibiotic recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Pantoprazole 30MG IN NS, Syringe, antimetic recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	D5 NS, Sentara Home Infusion Pharmacy Services recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Fluconazole 200MG NS, antifungal recalled by Sentara Infusion Services	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Ceftriaxone (a) 2GM in NS, (b) 4GM IN NS, Antibiotic recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Kytril 350MCG IN NS Syringe, antimetic recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	0.9% Sodium Chloride, used as a diluent or hydration recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Vitamin K(phytonadione) 2.5mg Syringe recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Dextrose 10%, TPN recalled by Sentara Infusion Services	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	D5W1/2NS W/ 77MEQ OF SOD Acetate, Hydration recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Morphine Sulfate (a) 1MG/ML IN NS, (b) 5MG/ML IN NS, pain recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Lactated Ringers recalled by Sentara Infusion Services	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Dobutamine, (a) 1080MG IN D5W, (b) 760MG IN D5W, ionotrop recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Ampicillin/Sulbactam 3GM IN NS, antibiotic recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Caspofungin 50MG IN NS, used with a Homepump recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Mycamine 100MG IN NS, antifungal recalled by Sentara Infusion Services	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Vancomycin (a) 1.25GM IN NS, (b) 1.5GM IN NS recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Sodium Chloride 0.9 % (a) (Magnesium) (b), (c), (d), (e) recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Milrinone (a) 104MG IN 0.45% NS,(b) 108MG IN 0.45% NS recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Ganciclovir ( Cytovene) (a)1480MG IN NS, (b) 740 MG IN NS, antiviral recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Ceftriaxone (a) 1GM IN NS, (b)4GM IN NS, (c) 8GM IN NS, antibiotic recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Diphenhydramine 18mg in NS Syringe, antihistamine recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Ethanol 70% Syringe, Cathcare recalled by Sentara Infusion Services	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Daptomycin (a) 400MG IN NS, (b) 550MG IN NS, antibiotic recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	TPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP, (b)90GM/AA recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Ampicillin 12GM IN NS 600M, used with a Curlin pump recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Amikacin 450MG IN NS, Antibiotic, used in a Homepump recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023	CLASS II	Intralipid 18gm, Tpn recalled by Sentara Infusion Services	Sentara Infusion Services	Sterility	Nationwide

More recalls from Sentara Infusion Services

All 53

Reported	Class	Recall	Company	Reason	Where
22 Feb 2023Drug	CLASS II	Intralipid 18gm, Tpn recalled by Sentara Infusion Services	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023Drug	CLASS II	Amikacin 450MG IN NS, Antibiotic, used in a Homepump recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023Drug	CLASS II	Ampicillin 12GM IN NS 600M, used with a Curlin pump recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023Drug	CLASS II	TPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP, (b)90GM/AA recalled	Sentara Infusion Services	Sterility	Nationwide
22 Feb 2023Drug	CLASS II	Daptomycin (a) 400MG IN NS, (b) 550MG IN NS, antibiotic recalled	Sentara Infusion Services	Sterility	Nationwide

Other Daptomycin (a recalls

All 2

Reported	Class	Recall	Company	Reason	Where
22 Feb 2023Drug	CLASS II	Daptomycin (a) 400MG IN NS, (b) 550MG IN NS, antibiotic recalled	Sentara Infusion Services	Sterility	Nationwide