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 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, 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…
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 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…
Category
Distribution
1 state
SevereFDA (Drugs)··2015-07-08
Lincare Recalls Vancomycin HCl Bags Due to Sterility Concerns
Lincare, Inc. is recalling Vancomycin HCl bags compounded by United Medical IV Center because the sterility of the product is not assured.
Product
Vancomycin HCl, Vancomycin 1500mg / D5W 265mL, Qty: 2 265 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 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 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 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 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 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…
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 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 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…
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 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 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 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 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 Compounded Vancomycin and Heparin Due to Sterility Concerns
Lincare, Inc. is recalling compounded Vancomycin and Heparin products because the sterility of the product is not assured. The recall affects products distributed in Arkansas.
Product
VANC 50MCG/ML-HEP 100U/ML in 2ML, Packed in 2 mL Units, 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…
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 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…
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 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