Lincare, Inc.

FDA Regulatory Profile

Lincare, Inc. appears in FDA public data with 54 recalls, 0 510(k) clearances, 140 FDA inspections, and 1 compliance action on record. Its most recent recall (D-1157-2015, Class II) was initiated on May 28, 2015.

Summary

Total Recalls
54
510(k) Clearances
0
Inspections
140
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-1157-2015Class IITPN 3:1, 1800 ml Bags, Qty: 2, Base Formula NaCl 0.9%, Dextrose 70%, Travasol 10%, Intralipid 20%, WMay 28, 2015
D-1164-2015Class IITPN 3:1, 1090 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for InMay 28, 2015
D-1160-2015Class IITPN 3:1, 1440 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile WateMay 28, 2015
D-1158-2015Class IITPN 2:1, 200 ml Bags, Qty: 7, Base Formula NaCl 0.9%, Dextrose 70%, Trophamine 10%, Water for Inj; EMay 28, 2015
D-1205-2015Class IIGentamicin Sulfate, GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Qty: 7 30 mL Syringes, Rx Only. CompoundMay 28, 2015
D-1191-2015Class IIVancomycin HCl, Vancomycin 1500mg / D5W 265mL, Qty: 2 265 mL Bags, Rx Only. Compounded by: United MMay 28, 2015
D-1165-2015Class IITPN 3:1, 1844 mL Bags, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF 15%, IntralipMay 28, 2015
D-1193-2015Class IICefepime HCl, Cefepime 2 gm / NS 100 mL AccuFlo, Qty: 14 100 mL Bags, Rx Only. Compounded by: UniteMay 28, 2015
D-1163-2015Class IITPN 3:1, 1050 mL Bags, Qty: 6, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile WatMay 28, 2015
D-1203-2015Class IIFluorouracil 4250mg / D5W 285mL, Qty: 1 285 mL Bag, Rx Only. Compounded by: United Medical IV CenterMay 28, 2015
D-1181-2015Class IIVANCOMYCIN HCL 250mg / NS 6mL syringe, Packaged in 6 mL Syringes, Rx Only. Compounded by: United MedMay 28, 2015
D-1166-2015Class IIPenicillin G Potassium 5.4 MU/SW 240 mL AccuFlo, Qty: 4 240 mL Bags, Rx Only. Compounded by: UnitedMay 28, 2015
D-1156-2015Class IITPN 3:1, 997 ml without lipids Bags, Qty: 3, Base Formula Dextrose 70%, Travasol 10%, Water for Inj;May 28, 2015
D-1162-2015Class IITPN 3:1, 817 mL Bags, Qty: 5, Base Formula Dextrose 70%, Trophamine 10%, Intralipid 20%, Water for IMay 28, 2015
D-1154-2015Class IITPN 3:1, 2000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile WateMay 28, 2015
D-1155-2015Class IITPN 3:1, 997 ml with lipids Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, May 28, 2015
D-1198-2015Class IIPotassium Chloride, Dextrose 5% LR 1000 mL with 40mEq KCL, Qty: 1 1000 mL Bag, Rx Only. Compounded bMay 28, 2015
D-1182-2015Class IIVANC 50MCG/ML-HEP 100U/ML in 2ML, Packed in 2 mL Units, Rx Only. Compounded by: United Medical IV CMay 28, 2015
D-1185-2015Class IICIPROFLOXACIN 400MG / D5W 200ML ACCUFLO, Packaged in 3 200 mL Bags, Rx Only. Compounded by: United MMay 28, 2015
D-1168-2015Class IIFluorouracil 5760mg / D5W 265mL Qty: 1 265 mL Bag, Rx Only. Compounded by: United Medical IV CenterMay 28, 2015