The Recall Desk

FDA (Drugs) recall action 72594

Walgreens Infusion Services recalled 33 products on 2016-01-06

The FDA (Drugs) publishes a recall like this one as 33 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 33 pages.

Products
33
Announced
2016-01-06
Critical
0
Units
958

Why these products were recalled

Lack of Assurance of Sterility

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 33

  • SevereFDA (Drugs)··2016-01-06

    Walgreens Recalls IVIG Gamunex Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling IVIG Gamunex bags in Texas because the sterility of the product cannot be assured.

    Product
    IVIG Gamunex 40 gm (400 mL) Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-01-06

    Walgreens Infusion Services Recalls Dextrose and Sodium Chloride Injection Bags

    Walgreens Infusion Services is recalling 9 bags of Dextrose 5% and 0.9% Sodium Chloride injection due to a lack of assurance of sterility.

    Product
    Dextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL, b) 3000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2016-01-06

    Walgreens Recalls Famotidine Injection Syringes Due to Sterility Concerns

    Walgreens Infusion Services is recalling 21 famotidine injection syringes compounded by Option Care 148 in Texas due to a lack of assurance of sterility.

    Product
    Famotidine injection syringe a) 10 mg/1 mL b) 80 mg/8 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-01-06

    Walgreens Recalls 3-in-1 TPN Formula Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling 87 bags of 3-in-1 TPN formula in Texas due to a lack of assurance of sterility.

    Product
    3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-01-06

    Walgreens Recalls Cefazolin Infusion Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling specific Cefazolin infusion bags compounded in Texas due to a lack of assurance of sterility.

    Product
    Cefazolin in Accuflo bags, a) 1g/NS 25 mL, b) 2g/NS 25 mL, c) 8g/NS 275 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Lack
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-01-06

    Walgreens Recalls Sodium Ascorbate Syringes Due to Sterility Concerns

    Walgreens Infusion Services is recalling compounded Sodium Ascorbate (Vitamin C) syringes in Texas due to a lack of assurance of sterility.

    Product
    Sodium Ascorbate (Vitamin C) syringe, a) 500 mg/1 mL syringe, b)1000 mg/2 mL c) 800 mg/1.6 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2016-01-06

    Walgreens Recalls Folic Acid Syringes Due to Sterility Concerns

    Walgreens Infusion Services is recalling 23 folic acid syringes compounded in Texas due to a lack of assurance of sterility.

    Product
    Folic Acid 1 mg/0.2 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-01-06

    Meropenem Infusion Minibags Recalled for Sterility Assurance Concerns

    Walgreens Infusion Services is recalling 35 Meropenem minibags distributed in Texas due to a lack of assurance of sterility.

    Product
    Meropenem 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-01-06

    Clindamycin Injection Bags Recalled for Lack of Sterility Assurance

    Walgreens Infusion Services is recalling Clindamycin injection Accuflo bags in Texas due to a lack of assurance of sterility.

    Product
    Clindamycin injection, Accuflo bag, a) 500 mg/NS 50 mL b) 900 mg/NS 100 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-01-06

    Walgreens Recalls Thiamine Syringes Due to Sterility Concerns

    Walgreens Infusion Services is recalling 23 Thiamine 100 mg syringes in Texas due to a lack of assurance of sterility.

    Product
    Thiamine 100 mg (1 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2016-01-06

    Walgreens Recalls Piperacillin/Tazobactam Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling 26 bags of Piperacillin/Tazobactam (Zosyn) Accuflo in Texas due to a lack of assurance of sterility.

    Product
    Piperacillin/Tazobactam (Zosyn) Accuflo bag, a) 18 g/NS 275 mL b) 4.5 g/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2016-01-06

    Walgreens Recalls Heparin Injection Syringes Due to Sterility Concerns

    Walgreens Infusion Services is recalling 49 syringes of Heparin injection, Preservative Free, due to a lack of assurance of sterility. The affected products were distributed in Texas.

    Product
    Heparin injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35 mL syringe, c) 440 units/0.44 mL, d) 500 units/0.5 mL syringe, e) Heparin 800 units/0.8 f) Heparin 2300 units/2.3 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-01-06

    Walgreens Recalls Pedi MVI Syringes Due to Sterility Concerns

    Walgreens Infusion Services is recalling 73 syringes of Pedi MVI in Texas due to a lack of assurance of sterility.

    Product
    Pedi MVI a) 5 mL, b) 10 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2016-01-06

    Walgreens Recalls L-Cysteine Syringes Due to Sterility Concerns

    Walgreens Infusion Services is recalling 14 L-Cysteine 800 mg syringes in Texas because the agency could not ensure the product was sterile.

    Product
    L-Cysteine 800 mg (16 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-01-06

    Gentamicin Syringes Recalled for Lack of Sterility Assurance

    Walgreens Infusion Services is recalling 27 prefilled Gentamicin syringes in Texas due to a lack of assurance of sterility.

    Product
    Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-01-06

    Walgreens Recalls Primaxin Infusion Minibags Due to Sterility Concerns

    Walgreens Infusion Services is recalling 40 minibags of Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL due to a lack of assurance of sterility. The affected products were distributed in Texas.

    Product
    Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2016-01-06

    Walgreens Recalls Milrinone Infusion Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling 19 bags of Milrinone 0.375 mcg/kg/min D5W in Texas due to a lack of assurance of sterility.

    Product
    Milrinone 0.375 mcg/kg/min D5W bag a) 365 mL, b) 400 mL c) 430 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-01-06

    Remicade Injection Recalled for Lack of Sterility Assurance

    Walgreens Infusion Services is recalling Remicade (Infliximab) injection bags in Texas due to a lack of assurance of sterility.

    Product
    Remicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-01-06

    Walgreens Recalls IVIG Gammagard Injection Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling five bags of IVIG Gammagard injection in Texas due to a lack of assurance of sterility.

    Product
    IVIG Gammagard injection bag, a) 13 gm, b) 20 gm, c) 73 gm, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-01-06

    Walgreens Recalls Oxacillin Infusion Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling 14 bags of compounded Oxacillin 12 g/NS 270 mL due to a lack of assurance of sterility. The product was distributed in Texas.

    Product
    Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-01-06

    Walgreens Recalls Invanz Minibags Due to Sterility Assurance Concerns

    Walgreens Infusion Services is recalling 52 Invanz minibags in Texas due to a lack of assurance of sterility. No illnesses have been reported.

    Product
    Invanz 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-01-06

    Walgreens Recalls Phytonadione Syringes Due to Sterility Concerns

    Walgreens Infusion Services is recalling compounded Phytonadione (Vitamin K) syringes in Texas due to a lack of assurance of sterility.

    Product
    Phytonadione (Vitamin K) 1 mg/0.1mL Syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2016-01-06

    Tobramycin Infusion Bags Recalled Due to Sterility Assurance Concerns

    Walgreens Infusion Services is recalling Tobramycin 620 mg/NS 100 mL Accuflo bags in Texas due to a lack of assurance of sterility.

    Product
    Tobramycin 620 mg/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Distribution
    1 state