The Recall Desk

FDA (Drugs) recall action 70600

Sagent Pharmaceuticals Inc recalled 2 products on 2015-03-11

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
2015-03-11
Critical
0
Units
281,570

Why these products were recalled

Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product 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.

States named across these recalls

1–2 of 2

  • SevereFDA (Drugs)··2015-03-11

    Sagent Pharmaceuticals Recalls Atracurium Besylate Injection Due to Sterility Concerns

    Sagent Pharmaceuticals is recalling Atracurium Besylate Injection vials because FDA observations regarding aseptic and GMP practices at the manufacturing site may have impacted product sterility.

    Product
    Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-03-11

    Sagent Pharmaceuticals Recalls Atracurium Besylate Injection Due to Sterility Concerns

    Sagent Pharmaceuticals is recalling Atracurium Besylate Injection vials because FDA observations suggest potential impacts on product sterility.

    Product
    Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10
    Category
    Distribution
    1 state