The Recall Desk

FDA (Drugs) recall action 86193

SCA Pharmaceuticals recalled 4 products on 2020-09-02

The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2020-09-02
Critical
3
Units
3,352

Why these products were recalled

Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.

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.

1–4 of 4

  • CriticalFDA (Drugs)··2020-09-02

    SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross Contamination

    SCA Pharmaceuticals is recalling Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL single-dose containers due to cross-contamination with undeclared benzyl alcohol.

    Product
    Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-46, Bar Code 70004065046.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-09-02

    SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross-Contamination

    SCA Pharmaceuticals is recalling Heparin Sodium 2,500 units injection containers that contain undeclared benzyl alcohol and lack declared parabens.

    Product
    Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0655-44, Bar Code 70004065544.
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2020-09-02

    SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross Contamination

    SCA Pharmaceuticals is recalling 366 containers of Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL due to cross-contamination with undeclared benzyl alcohol.

    Product
    Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-44, Bar Code 70004065044.
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2020-09-02

    SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross Contamination

    SCA Pharmaceuticals is recalling Heparin Sodium 10,000 units injection containers due to cross contamination with undeclared benzyl alcohol and missing parabens.

    Product
    Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0652-46, Bar Code 70004065246.
    Category
    Distribution
    0 states