The Recall Desk

FDA (Drugs) recall action 90956

Exela Pharma Sciences LLC recalled 2 products on 2022-11-02

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
2022-11-02
Critical
0
Units
2,271,960

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)··2022-11-02

    Sodium Bicarbonate Injection Recalled for Defective Vials and Glass Breakage

    Nationwide recall of 8.4% sodium bicarbonate injection vials due to container defects causing vial breakage and glass fragments when pressurized during preparation.

    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