The Recall Desk

FDA (Drugs) recall action 83497

Akorn, Inc. recalled 3 products on 2019-09-04

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
2019-09-04
Critical
0
Units
12,920

Why these products were recalled

Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.

Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.

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

  • LowFDA (Drugs)··2019-09-04

    Akorn Recalls Eptifibatide Injection Vials Due to Impurity

    Akorn, Inc. is recalling 4,085 vials of Eptifibatide Injection because they failed impurity specifications for D-aspartic acid.

    Product
    Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-903-90.
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2019-09-04

    Akorn Recalls Eptifibatide Injection Vials Due to Impurity

    Akorn, Inc. is recalling Eptifibatide Injection vials because they failed impurity specifications for D-aspartic acid.

    Product
    Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-902-10, b) 200 mg/100 mL (2 mg/mL), 100 mL Single-use Vial, NDC 17478-902-90, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045.
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2019-09-04

    Akorn Recalls Eptifibatide Injection Vials Due to Fill Volume and Impurity Issues

    Akorn, Inc. is recalling 648 vials of Eptifibatide Injection because the fill volume was below specification and a known impurity exceeded limits.

    Product
    Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045, NDC 17478-903-90.
    Category
    Distribution
    0 states