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

1–25 of 54

  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Deferoxamine Mesylate IV Bags Due to Sterility Concerns

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

    Product
    DEFEROXAMINE MESYLATE 3gm / NS 240mL Accuflo, Packaged in 240 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 Ganciclovir Sodium Bags Due to Sterility Concerns

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

    Product
    Ganciclovir Sodium, 250MG / NS 100ML, QTY: 6 100 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 Penicillin G Potassium IV Bags Due to Sterility Concerns

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

    Product
    Penicillin G Potassium 5.4 MU/SW 240 mL AccuFlo, Qty: 4 240 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Hydrocodone IV Bags Due to Sterility Concerns

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

    Product
    HYDROmorphone HCl PF, HYDROMORPHONE HCL 1000mg /NS 500mL, 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 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, 2000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes K Acetate, Na Acetate, Famotidine, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Salenium, Multi Vitamin, Vitamin K, Ascorbic Acid, R
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Ceftazidime IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling compounded Ceftazidime IV bags because the sterility of the product is not assured.

    Product
    Ceftazidime 2 gm / NS 50mL, Qty: 15 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 Cefepime 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 2 gm / NS 100 mL AccuFlo, Qty: 14 100 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 Ceftriaxone Sodium Due to Sterility Concerns

    Lincare, Inc. is recalling compounded Ceftriaxone Sodium IV bags because the sterility of the product is not assured.

    Product
    CefTRIAXone Sodium, Ceftriaxone 1 gram / NS 50 mL, Qty: 10 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Potassium Chloride IV Bags Due to Sterility Concerns

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

    Product
    Potassium Chloride, Dextrose 5% LR 1000 mL with 40mEq KCL, Qty: 1 1000 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 Morphine Sulfate Bags Due to Sterility Concerns

    Lincare, Inc. is recalling specific compounded Morphine Sulfate bags because the sterility of the product is not assured. The affected bags were distributed in Arkansas.

    Product
    Morphine Sulfate, MORPHINE SULFATE 1000mg / NS 100mL, Qty: 1 50 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 2:1 Bags Due to Sterility Concerns

    Lincare, Inc. is recalling TPN 2:1 bags compounded between May 14 and May 27, 2015, because the sterility of the product is not assured.

    Product
    TPN 2:1, 200 ml Bags, Qty: 7, Base Formula NaCl 0.9%, Dextrose 70%, Trophamine 10%, Water for Inj; Electrolytes Calcium Gluc, MgSO4, Na Phos, KCL; Vitamins, trace elements and medications Copper Cl, Selenium, Zinc Sulfate, Infuvite Pediat, 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, 1440 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes Calcium Gluc, Na Phos, Na Acetate, MgSO4, K Acetate; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Folic Acid, Rx Only. Compounded by: Unite
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Pfizerpen-G IV Bags Due to Sterility Concerns

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

    Product
    Pfizerpen-G 4.2 MU / SW 240 mL AccuFlo, Packaged in 2 240 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 Vancomycin IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Vancomycin HCl in Dextrose IV bags because the sterility of the product is not assured. The affected bags were compounded in Arkansas.

    Product
    Vancomycin HCl in Dextrose, VANCOMYCIN 500mg / D5W 100mL AccuFlo, Qty: 12 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.
    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, 997 ml without lipids Bags, Qty: 3, Base Formula Dextrose 70%, Travasol 10%, 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, Infuvitm Pediat, Rx O
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Vancomycin Bags Due to Sterility Assurance Concerns

    Lincare, Inc. is recalling 2 bags of Vancomycin 750 mg/NS 100 ml compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Vancomycin 750 mg/NS 100 ml accuflo, Packaged in 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 Ciprofloxacin IV Bags Due to Sterility Concerns

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

    Product
    CIPROFLOXACIN 400MG / D5W 200ML ACCUFLO, Packaged in 3 200 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 Ceftriaxone Sodium IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Ceftriaxone Sodium IV bags because the sterility of the product is not assured. The affected units were distributed in Arkansas.

    Product
    CEFTRIAXONE SODIUM 2000mg / NS 50mL, Qty:4 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 between May 14 and May 27, 2015, because the sterility of the product is not assured.

    Product
    TPN 3:1, 2250 mL Bags, Qty: 5, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF 15%, Intralipid 20%, Water for Inj; Electrolytes KCL, K Phos, Famotidine, Na Acetate, MgSO4; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Rx Only. Compounded by: United
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Vancomycin IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Vancomycin 1000mg IV bags compounded by United Medical IV Center in Arkansas because the sterility of the product is not assured.

    Product
    Vancomycin 1000mg / NS 100mL, Packaged in 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 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, 817 mL Bags, Qty: 5, Base Formula Dextrose 70%, Trophamine 10%, Intralipid 20%, Water for Inj; Electrolytes K Phos, KCL, MgSO4, NaCl, Ca Gluconate; Vitamins, trace elements and medications Trace Ele.-Ped, Infuvite Pediat, Carnitor, Rx Only. Compounded by: United Medical
    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, 1750 mL Bags, Qty: 5, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes Famotidine, KCL, K Phos, Na Acetate, MgSO4, NaCl; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Vitamin K, Rx Only. Compounded by: United M
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Ceftriaxone Sodium Due to Sterility Concerns

    Lincare, Inc. is recalling compounded Ceftriaxone Sodium IV bags because the sterility of the product is not assured. The recall affects units distributed in Arkansas.

    Product
    Ceftriaxone Sodium, Ceftriaxone 2gm / NS 50mL, 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 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 5760mg / D5W 265mL Qty: 1 265 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-08

    Lincare Recalls Cefepime IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling 3 bags of Cefepime 1gm/NS 50mL AccuFlo compounded in Little Rock, Arkansas, because the sterility of the product is not assured.

    Product
    CEFEPIME 1gm / NS 50mL AccuFlo, Packaged in 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