CLASS II Drug recall · Reported 8 Jul 2015 · FDA Enforcement Report

TPN 3:1 with lipids, Qty: 7, Base Formula Dextrose recalled by Lincare

Lincare is recalling TPN 3:1 with lipids, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, distributed in Arkansas. The recall was initiated on 28 May 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll product compounded between May 14, 2015 and May 27, 2015
Quantity recalled4 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-1155-2015
FDA event ID
71415
Recalling firm
Lincare, Little Rock, AR
Classification
Class II
Status
Terminated
Recall initiated
28 May 2015
FDA classified
1 Jul 2015
Reported
8 Jul 2015
Type
Voluntary: Firm initiated
Customers notified by
Telephone
Reason category
Sterility

Timeline

28 May 2015Recall initiated by company
1 Jul 2015Classified by FDA+34 days
8 Jul 2015Published 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 Assurance of Sterility: Sterility of product is not assured.

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

TPN 3:1, 997 ml with lipids Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes K Acetate, Na Acetate, KCL, Na Phos, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Selenium, Copper Cl, Carnitor, Rx Only. United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Where it was distributed

United States including: Arkansas

Arkansas

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: Sterility of product is not assured.

Which lots are affected?

All product compounded between May 14, 2015 and May 27, 2015

Where was it sold?

United States including: Arkansas

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

53 other products · FDA event 71415

This product is part of a recall event; the main page for the event is Morphine Sulfate, Morphine Sulfate 1000mg / NS, Qty recalled by Lincare.

ReportedClassRecallCompanyReasonWhere
CLASS IIMorphine Sulfate, Morphine Sulfate 1000mg / NS, Qty recalled by LincareLincareSterilityAR
CLASS IITPN 2:1, Qty: 7, Base Formula NaCl 0.9%, Dextrose recalled by LincareLincareSterilityAR
CLASS IIVancomycin, Vancomycin 750mg / NS AccuFlo, Qty recalled by LincareLincareSterilityAR
CLASS IIFluorouracil 1400mg / D5W Qty recalled by LincareLincareSterilityAR
CLASS IIPotassium Chloride, Dextrose 5% LR with 40mEq KCL, Qty recalledLincareSterilityAR
CLASS IIFluorouracil 1200mg / D5W, Qty recalled by LincareLincareSterilityAR
CLASS IICefepime HCl, Cefepime 2 gm / NS AccuFlo, Qty recalled by LincareLincareSterilityAR
CLASS IIVancomycin HCl in Dextrose, Vancomycin 750mg / D5W, Qty recalledLincareSterilityAR
CLASS IICefTRIAXone Sodium, Ceftriaxone / NS, Qty recalled by LincareLincareSterilityAR
CLASS IITPN 3:1, Qty: 7, Base Formula Dextrose 70%, Travasol recalled by LincareLincareSterilityAR
CLASS IIGanciclovir Sodium, 250MG / NS, QTY recalled by LincareLincareSterilityAR
CLASS IIHYDROmorphone HCl PF, Hydromorphone HCL 1000mg /NS, Qty recalledLincareSterilityAR
CLASS IIGentamicin 14.4 mg / NS Syringe recalled by LincareLincareSterilityAR
CLASS IIDiphenhydramine HCl, Diphenhydramine 25mg / NS syringe, Qty recalledLincareSterilityAR
CLASS IITPN 3:1, Qty: 7, Base Formula Dextrose 70%, Travasol recalled by LincareLincareSterilityAR
CLASS IIPfizerpen-G 4.2 MU / SW AccuFlo recalled by LincareLincareSterilityAR
CLASS IIFluorouracil 4800mg / D5W, Qty recalled by LincareLincareSterilityAR
CLASS IIVancomycin HCl in Dextrose, Vancomycin 500mg / D5W AccuFlo, Qty recalledLincareSterilityAR
CLASS IIVancomycin HCl in Dextrose, Vancomycin 750mg / D5W, Qty recalledLincareSterilityAR
CLASS IIVancomycin 1.25gm / NS AccuFlo, Qty recalled by LincareLincareSterilityAR
CLASS IITPN 3:1 without lipids, Qty: 3, Base Formula Dextrose recalledLincareSterilityAR
CLASS IIVancomycin 750 mg/NS accuflo recalled by LincareLincareSterilityAR
CLASS IITPN 3:1, Qty: 7, Base Formula Dextrose 70%, Travasol recalled by LincareLincareSterilityAR
CLASS IIFluorouracil 1560MG / D5W, Qty recalled by LincareLincareSterilityAR
CLASS IIDeferoxamine Mesylate 3gm / NS Accuflo recalled by LincareLincareSterilityAR
CLASS IICiprofloxacin 400mg / D5w Accuflo recalled by LincareLincareSterilityAR
CLASS IITPN 3:1, Qty: 6, Base Formula Sodium Chloride, Dextrose recalledLincareSterilityAR
CLASS IIVancomycin HCl / Heparin, Vancomycin 50mcg/ml / Heparin recalledLincareSterilityAR
CLASS IITPN 3:1, Qty: 6, Base Formula Sodium Chloride, Dextrose recalledLincareSterilityAR
CLASS IITPN 3:1, Qty: 7, Base Formula Dextrose 70%, Travasol recalled by LincareLincareSterilityAR
CLASS IIVancomycin HCl/Heparin, Vancomycin 50mcg/mL / Heparin recalledLincareSterilityAR
CLASS IIFluorouracil 3200mg / D5W, Qty recalled by LincareLincareSterilityAR
CLASS IIFentanyl Citrate, Fentanyl 25,000 MCG /, Qty recalled by LincareLincareSterilityAR
CLASS IITPN 3:1, Qty: 5, Base Formula Sodium Chloride, Dextrose recalledLincareSterilityAR
CLASS IIVancomycin 1000mg / NS recalled by LincareLincareSterilityAR
CLASS IICeftriaxone Sodium 2000mg / NS, Qty:4 recalled by LincareLincareSterilityAR
CLASS IITPN 3:1, Qty: 5, Base Formula Dextrose 70%, Trophamine recalledLincareSterilityAR
CLASS IICefepime HCl, Cefepime 850 mg NS AccuFlo, Qty recalled by LincareLincareSterilityAR
CLASS IITPN 3:1, Qty: 6, Base Formula Dextrose 70%, Travasol recalled by LincareLincareSterilityAR
CLASS IIVancomycin HCl, Vancomycin 1500mg / D5W, Qty recalled by LincareLincareSterilityAR
CLASS IITPN 3:1, Qty: 5, Base Formula Dextrose 70%, Travasol recalled by LincareLincareSterilityAR
CLASS IIVanc 50mcg/ML-hep 100u/ML recalled by LincareLincareSterilityAR
CLASS IIGentamicin Sulfate, Gentamicin 14.4 mg / NS Syringe, Qty: 7 Syringes recalledLincareSterilityAR
CLASS IICeftazidime 2 gm / NS, Qty recalled by LincareLincareSterilityAR
CLASS IIHYDROmorphone HCl PF, Hydromorphone 1000 mg / NS, Qty recalledLincareSterilityAR
CLASS IIPenicillin G Potassium 5.4 MU/SW AccuFlo, Qty recalled by LincareLincareSterilityAR
CLASS IICeftriaxone Sodium, Ceftriaxone 2gm / NS, Qty recalled by LincareLincareSterilityAR
CLASS IIFluorouracil 5760mg / D5W Qty recalled by LincareLincareSterilityAR
CLASS IICefepime 1gm / NS AccuFlo recalled by LincareLincareSterilityAR
CLASS IIVancomycin HCL 250mg / NS syringe recalled by LincareLincareSterilityAR
CLASS IIFluorouracil 4600mg / D5W, Qty recalled by LincareLincareSterilityAR
CLASS IITPN 3:1, Qty: 2, Base Formula NaCl 0.9%, Dextrose recalled by LincareLincareSterilityAR
CLASS IIFluorouracil 4250mg / D5W, Qty recalled by LincareLincareSterilityAR

More recalls from Lincare

All 54
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIFluorouracil 4250mg / D5W, Qty recalled by LincareLincareSterilityAR
DrugCLASS IITPN 3:1, Qty: 2, Base Formula NaCl 0.9%, Dextrose recalled by LincareLincareSterilityAR
DrugCLASS IIFluorouracil 4600mg / D5W, Qty recalled by LincareLincareSterilityAR
DrugCLASS IIVancomycin HCL 250mg / NS syringe recalled by LincareLincareSterilityAR
DrugCLASS IICefepime 1gm / NS AccuFlo recalled by LincareLincareSterilityAR