The Recall Desk

FDA (Drugs) recall action 77777

SCA Pharmaceuticals recalled 6 products on 2017-08-02

The FDA (Drugs) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2017-08-02
Critical
0
Units
620

Why these products were recalled

Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.

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.

1–6 of 6

  • SevereFDA (Drugs)··2017-08-02

    SCA Pharmaceuticals Recalls CeFAZolin Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 108 bags of CeFAZolin 3 g in 0.9% Sodium Chloride because the product was made with recalled saline bags that may leak, compromising sterility.

    Product
    ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0524-32.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-08-02

    SCA Pharmaceuticals Recalls Phenylephrine HCl Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling two bags of Phenylephrine HCl 10 mg in 0.9% Sodium Chloride because they were made with recalled saline bags that may leak.

    Product
    PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0810-32.
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    0 states
  • SevereFDA (Drugs)··2017-08-02

    SCA Pharmaceuticals Recalls Fentanyl Citrate Injection Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 130 bags of fentanyl citrate injection due to a lack of assurance of sterility caused by potential leaks in the sodium chloride bags used.

    Product
    fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, (Total fentaNYL Dose 1,000 mcg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0202-32.
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    0 states
  • SevereFDA (Drugs)··2017-08-02

    SCA Pharmaceuticals Recalls Magnesium Sulfate Injection Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 40 bags of Magnesium Sulfate 4 g in 0.9% Sodium Chloride because they were made with recalled saline bags that may leak, compromising sterility.

    Product
    MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0737-32.
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    0 states
  • HighFDA (Drugs)··2017-08-02

    SCA Pharmaceuticals Recalls Morphine Sulfate Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 220 bags of morphine sulfate in 0.9% sodium chloride because the product was made with recalled saline bags that may leak, compromising sterility.

    Product
    morphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 100 mg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, (877) 550-5059; labeled as a) NDC: 70004-0100-59; b) NDC: 70004-100-58.
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    0 states
  • SevereFDA (Drugs)··2017-08-02

    SCA Pharmaceuticals Recalls Diltiazem Injection Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling Diltiazem 125 mg injection bags because they were made with recalled saline bags that may leak, compromising sterility.

    Product
    Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0541-35.
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    Distribution
    0 states