The Recall Desk

FDA (Devices) recall action 73395

Nephron Pharmaceuticals Corp. recalled 2 products on 2016-07-06

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2016-07-06
Critical
0
Units
24,900

Why these products were recalled

Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.

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

1–2 of 2

  • HighFDA (Devices)··2016-07-06

    Nephron Recalls Sodium Chloride Inhalation Solution Due to Sterility Concerns

    Nephron Pharmaceuticals is recalling 11,208 cartons of Sodium Chloride Inhalation Solution because internal dye tests failed to confirm vial integrity.

    Product
    Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indica
    Category
    Distribution
    36 states
  • HighFDA (Devices)··2016-07-06

    Nephron Recalls Sodium Chloride Inhalation Solution Due to Sterility Concerns

    Nephron Pharmaceuticals is recalling 13,692 cartons of Sodium Chloride Inhalation Solution due to a failure in the internal dye ingress test, which raises concerns about the sterility of the vials.

    Product
    Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For res
    Category
    Distribution
    36 states