The Recall Desk

FDA (Drugs) recall action 80307

Avella of Deer Valley, Inc. Store 38 recalled 38 products on 2018-07-25

The FDA (Drugs) publishes a recall like this one as 38 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 38 pages.

Products
38
Announced
2018-07-25
Critical
0
Units
39,027

Why these products were recalled

Lack of Assurance of Sterility: Potential leakage of bags.

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.

26–38 of 38

  • SevereFDA (Drugs)··2018-07-25

    Avella Recalls Magnesium Sulfate Bags Due to Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 25 bags of Magnesium Sulfate in Sodium Chloride due to potential leakage and lack of sterility assurance.

    Product
    MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 102 mL. Single dose bag. For: Salt Lake Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-906-10
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    0 states
  • SevereFDA (Drugs)··2018-07-25

    Avella Recalls Magnesium Sulfate Bags Due to Sterility Concerns

    Avella of Deer Valley is recalling 175 bags of Magnesium Sulfate in Sodium Chloride due to potential bag leakage and lack of sterility assurance.

    Product
    MAGnesium 2gm in NS 100 mL (MAGnesium SULfate (USP) 2 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 104 mL. Single dose bag. For: Desert Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-907-10
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    0 states
  • SevereFDA (Drugs)··2018-07-25

    Avella Recalls Epinephrine Bags Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley is recalling 420 bags of Epinephrine 4 mg in 5% Dextrose due to potential leakage that compromises sterility.

    Product
    EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag. For: Peninsular Regional Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-855-25.
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    0 states
  • HighFDA (Drugs)··2018-07-25

    Avella Recalls Heparin Bags Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 40 bags of Heparin 1,000 Units in NS 250mL due to potential leakage that compromises sterility.

    Product
    HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride, USP 250 mL) Volume: 251 mL. Single dose bag. For: Adventist Medical Center Hanford. By: Avella of Huston, 9265 Kirby Dr., Houston TX, 77054. NDC 42852-747-25
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    0 states
  • SevereFDA (Drugs)··2018-07-25

    Avella Recalls Midazolam Syringes Due to Sterility Assurance Concerns

    Avella of Deer Valley, Inc. is recalling 110 syringes of Midazolam 1 mg/mL due to a lack of assurance of sterility and potential bag leakage.

    Product
    Midazolam 1 mg/mL (Midazolam HCL (USP) 55 mg, 0.9% Sodium Chloride, (USP) QS 55 mL) Volume: 55mL. Single dose syringe. Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-401-76
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    0 states
  • SevereFDA (Drugs)··2018-07-25

    Avella Recalls Morphine Bags Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley is recalling 130 bags of Morphine 1 mg/mL due to potential bag leakage and lack of assurance of sterility.

    Product
    MORphine 1 mg/mL (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 mL). Volume 255 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-25
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  • SevereFDA (Drugs)··2018-07-25

    Avella Recalls Fentanyl Syringes Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley is recalling 120 fentanyl syringes due to potential bag leakage and lack of assurance of sterility.

    Product
    fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Single dose Syringe. For: Hunt Regional Medical Center, By: Advanced Pharma, 9265 Kirby Dr,., Houston, TX 77054. NDC 15082-210-70
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    0 states
  • HighFDA (Drugs)··2018-07-25

    Avella Recalls Heparin Bags Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley is recalling 240 bags of Heparin 25,000 Units in 5% Dextrose due to potential bag leakage and lack of sterility assurance.

    Product
    HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj., USP 250 mL) Volume: 255 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix AZ 85085. NDC 42852-729-25
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    0 states
  • SevereFDA (Drugs)··2018-07-25

    Avella Recalls Heparin Bags Due to Potential Sterility Issues

    Avella of Deer Valley is recalling 900 bags of Heparin 12,500 Units in 5% Dextrose due to potential bag leakage and lack of sterility assurance.

    Product
    HEPARIN 12,500 Units in 5% Dextrose. (Heparin Sodium, USP 12,500 Units, 5% Dextrose Inj., USP 250 mL) Volume: 252.5 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue Phoenix, AZ 85085. NDC 42852-745-25
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    0 states
  • SevereFDA (Drugs)··2018-07-25

    Avella Recalls Phenylephrine Bags Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley is recalling 40 bags of Phenylephrine 10 mg due to potential leakage that compromises sterility. The product was distributed nationwide.

    Product
    PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL. Volume: 251 mL Single dose bag. For: Redlands Community Hospital Pharmacy. BY: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 NDC 15082-856-25
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    0 states
  • HighFDA (Drugs)··2018-07-25

    Avella Recalls Fentanyl and Bupivacaine Cassettes Due to Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 15 cassettes of fentanyl and bupivacaine due to potential bag leakage and lack of sterility assurance.

    Product
    fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacaine HCL PF, USP, 250 mg, 0.9% Sodium Chloride, USP QS 250 mL. Volume: 250mL. Single dose Cassette. For: Methodist St. John Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-250-8
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    0 states
  • SevereFDA (Drugs)··2018-07-25

    Avella Recalls Magnesium Sulfate Bags Due to Sterility Concerns

    Avella of Deer Valley is recalling 100 bags of Magnesium Sulfate in Sodium Chloride due to potential bag leakage and lack of sterility assurance.

    Product
    MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 108 mL. Single dose bag. For: Gaston Memorial Hospital By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-905-10
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  • SevereFDA (Drugs)··2018-07-25

    Avella Recalls Fentanyl and Ropivacaine Cassettes Due to Sterility Concerns

    Avella of Deer Valley is recalling 100 fentanyl and ropivacaine cassettes due to potential bag leakage and lack of sterility assurance.

    Product
    fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropivacaine HCL PF, USP 187.5 mg, 0.9% Sodium Chloride, USP QS 150 mL. Volume: 150 mL. Single dose cassette For: Methodist Dallas Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 150
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