The Recall Desk

FDA (Drugs) recall action 92678

Sagent Pharmaceuticals recalled 3 products on 2023-08-02

The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2023-08-02
Critical
0
Units
760

Why these products were recalled

Lack of Assurance of Sterility

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.

1–3 of 3

  • HighFDA (Drugs)··2023-08-02

    Oxacillin for Injection Recalled Nationwide for Lack of Sterility Assurance

    Sagent Pharmaceuticals is recalling Oxacillin for Injection due to lack of assurance of sterility. The product was distributed to healthcare facilities nationwide.

    Product
    Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-08-02

    Oxacillin Injectable Recalled for Failure to Assure Sterility

    Sagent Pharmaceuticals is recalling Oxacillin for Injection (1 gram vials, Lot OXG301) due to lack of assured sterility. Approximately 65,710 vials distributed nationwide are affected.

    Product
    Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-08-02

    Oxacillin for Injection recalled nationwide due to sterility concerns

    Sagent Pharmaceuticals is recalling Oxacillin for Injection USP due to lack of sterility assurance. The recall affects multiple lots distributed nationwide.

    Product
    Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
    Category
    Distribution
    0 states