The Recall Desk

FDA (Drugs) recall action 71415

Lincare, Inc. recalled 54 products on 2015-07-08

The FDA (Drugs) publishes a recall like this one as 54 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 54 pages.

Products
54
Announced
2015-07-08
Critical
0
Units
245

Why these products were recalled

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

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

Lack of Assurance of Sterility: Sterility of product is not assure

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.

States named across these recalls

26–50 of 54

  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Vancomycin Syringes Due to Sterility Assurance Concerns

    Lincare, Inc. is recalling Vancomycin HCL 250mg syringes compounded by United Medical IV Center in Arkansas because the sterility of the product is not assured.

    Product
    VANCOMYCIN HCL 250mg / NS 6mL syringe, Packaged in 6 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Fluorouracil IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Fluorouracil 4600mg / D5W 292 mL, Qty: 1 292 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns

    Lincare, Inc. is recalling TPN 3:1 bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    TPN 3:1, 1800 ml Bags, Qty: 2, Base Formula NaCl 0.9%, Dextrose 70%, Travasol 10%, Intralipid 20%, Water; Electrolytes K Phos, Mag Sulfate, KCL, Ca Gluconate; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Rx Only. Compounded by: United Medical IV Center (
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Fluorouracil IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Fluorouracil 4250mg / D5W 285mL, Qty: 1 285 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Vancomycin IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Vancomycin IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Vancomycin, VANCOMYCIN 750mg / NS 100mL AccuFlo, Qty: 7 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Fentanyl Citrate IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Fentanyl Citrate IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Fentanyl Citrate, FENTANYL 25,000 MCG / 500 ML, Qty: 1 500 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Vancomycin IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Vancomycin IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    VANCOMYCIN 1.25gm / NS 250mL AccuFlo, Qty: 7 250 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Fluorouracil IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Fluorouracil 1400mg / D5W 278mL Qty: 1 278 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns

    Lincare, Inc. is recalling specific TPN 3:1 bags because their sterility is not assured. The affected products were compounded in May 2015 and distributed in Arkansas.

    Product
    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
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Fluorouracil 1200mg IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Fluorouracil 1200mg / D5W 274mL, Qty: 1 274 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Vancomycin HCl in Dextrose Due to Sterility Concerns

    Lincare, Inc. is recalling Vancomycin HCl in Dextrose compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Vancomycin HCl in Dextrose, VANCOMYCIN 750mg / D5W 150mL, Qty: 12 150 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns

    Lincare, Inc. is recalling TPN 3:1 bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    TPN 3:1, 3000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes Famotidine, MgSO4, KCL, NaC, Zinc Cl; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Vitamin K, Ascorbic Acid, Rx Only. Compounded by: United
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Gentamicin Syringes Due to Sterility Concerns

    Lincare, Inc. is recalling Gentamicin 14.4 mg syringes because the sterility of the product is not assured. The recall affects 2 syringes distributed in Arkansas.

    Product
    GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Packaged in 30 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Diphenhydramine Syringes Due to Sterility Concerns

    Lincare, Inc. is recalling compounded Diphenhydramine HCl syringes because the sterility of the product is not assured.

    Product
    Diphenhydramine HCl, Diphenhydramine 25mg / NS 10 ml syringe, Qty: 2 10 mL syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Fluorouracil 4800mg IV bags compounded in Arkansas because the sterility of the product is not assured.

    Product
    Fluorouracil 4800mg / D5W 296mL, Qty: 1 296 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Vancomycin HCl in Dextrose Due to Sterility Concerns

    Lincare, Inc. is recalling Vancomycin HCl in Dextrose compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Vancomycin HCl in Dextrose, VANCOMYCIN 750mg / D5W 150mL, Qty: 6 150 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Fluorouracil Bags Due to Sterility Concerns

    Lincare, Inc. is recalling specific Fluorouracil IV bags because the sterility of the product is not assured.

    Product
    FLUOROURACIL 1560MG / D5W 281ML, Qty: 1 281 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Vancomycin HCl / Heparin Due to Sterility Concerns

    Lincare, Inc. is recalling Vancomycin HCl / Heparin compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Vancomycin HCl / Heparin, Vancomycin 50mcg/ml / HEPARIN 100u/ml, Qty: 8, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns

    Lincare, Inc. is recalling TPN 3:1 bags compounded in May 2015 because the sterility of the product is not assured.

    Product
    TPN 3:1, 1844 mL Bags, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF 15%, Intralipid 20%, Water for Inj; Electrolytes KCL, Ca Gluconate, MgSO4, K Phos; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Rx Only. Compounded by: United Medical I
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns

    Lincare, Inc. is recalling TPN 3:1 bags compounded between May 14 and May 27, 2015, because the sterility of the product is not assured.

    Product
    TPN 3:1, 2400 mL Bag, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj.; Electrolytes KCL, K Acetate, Na Acetate, K Phos, MgSO4; Vitamins, trace elements and medications Trace Ele. -Ped, Multi Vitamin, Rx Only, Compounded by: United
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns

    Lincare, Inc. is recalling TPN 3:1 bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    TPN 3:1, 1090 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes K Phos, KCL, MgSO4, NaCl, Ca Gluconate, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-2
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Vancomycin HCl/Heparin Due to Sterility Concerns

    Lincare, Inc. is recalling Vancomycin HCl/Heparin compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Vancomycin HCl/Heparin, Vancomycin 50mcg/mL / Heparin 100u/mL, Qty: 3, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Fluorouracil IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Fluorouracil 3200mg / D5W 264mL, Qty: 1 264 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Cefepime HCl IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Cefepime HCl IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Cefepime HCl, CEFEPIME 850 mg NS 50mL AccuFlo, Qty: 12 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns

    Lincare, Inc. is recalling TPN 3:1 bags compounded in Arkansas between May 14 and May 27, 2015, because the sterility of the product is not assured.

    Product
    TPN 3:1, 1050 mL Bags, Qty: 6, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes KCL, K Phos, MgSO4, NaCl, Zinc Cl, Ca Gluconate; Vitamins, trace elements and medications Trace Ele.-Ped, Infuvite Pediat, Carnitor, Rx Only. Compounded by: United
    Category
    Distribution
    1 state