The Recall Desk

FDA (Drugs) recall action 77600

SCA Pharmaceuticals recalled 4 products on 2017-07-19

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
2017-07-19
Critical
0
Units
921

Why these products were recalled

Lack of sterility assurance

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

1–4 of 4

  • SevereFDA (Drugs)··2017-07-19

    SCA Pharmaceuticals Recalls Potassium Phosphate IV Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 660 bags of Potassium Phosphate IV solution due to a lack of sterility assurance. The product was distributed in LA, PA, NY, and WI.

    Product
    Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-40
    Category
    Distribution
    4 states
  • SevereFDA (Drugs)··2017-07-19

    SCA Pharmaceuticals Recalls Potassium Phosphate IV Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 20 bags of Potassium Phosphate IV solution due to a lack of sterility assurance. The affected product was distributed in LA, PA, NY, and WI.

    Product
    Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq K+) Total Approximate Volume 260 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0843-40
    Category
    Distribution
    4 states
  • SevereFDA (Drugs)··2017-07-19

    SCA Pharmaceuticals Recalls Potassium Phosphate IV Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 20 bags of Potassium Phosphate IV solution due to a lack of sterility assurance. The affected product was distributed in LA, PA, NY, and WI.

    Product
    Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-32
    Category
    Distribution
    4 states
  • SevereFDA (Drugs)··2017-07-19

    SCA Pharmaceuticals Recalls Potassium Phosphate IV Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 221 bags of Potassium Phosphate IV solution due to a lack of sterility assurance. The product was distributed in LA, PA, NY, and WI.

    Product
    Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0840-40
    Category
    Distribution
    4 states