The Recall Desk

FDA (Drugs) recall action 91197

Exela Pharma Sciences LLC recalled 2 products on 2022-12-21

The FDA (Drugs) 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
2022-12-21
Critical
0
Units
526,920

Why these products were recalled

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

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.

1–2 of 2

  • SevereFDA (Drugs)··2022-12-21

    FDA Recalls Sodium Bicarbonate Injection Vials for Glass Breakage Risk

    Exela Pharma Sciences is recalling Sodium Bicarbonate Injection vials due to defective containers that may break and release glass fragments when pressurized during preparation. The recall affects 37,320 vials distributed nationwide.

    Product
    8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2022-12-21

    FDA Recalls Sodium Bicarbonate Injection for Defective Vials

    Exela Pharma Sciences is recalling 489,600 vials of sodium bicarbonate injection nationwide due to defective vials that break and release glass fragments when pressurized during preparation.

    Product
    SODIUM BICARBONATE (SODIUM BICARBONATE)
    Category
    Distribution
    0 states