FDA Seizes Contaminated Heparin from Cincinnati Manufacturer

As part of the U.S. Food and Drug Administration's ongoing efforts to ensure that heparin for patients remains safe, the government seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati.

The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity.

"This action will help prevent this contaminated heparin from finding its way into the marketplace," said Mike Chappell, acting associate commissioner for regulatory affairs, FDA.

FDA informed Celsus Laboratories during an April 2008 inspection and again in a May 8, 2008, letter that the company's actions to notify customers about a contaminant in its heparin were insufficient to assure an effective recall. The agency advises manufacturers who may have purchased heparin from Celsus to contact the company to make certain they are not using any heparin from the seized lots because the product does not meet acceptable quality standards.

Heparin is a blood-thinning drug. An API is a substance or mixture of substances that, when delivered in a finished drug product, directly affects the structure or function of the body. Heparin Sodium USP is an API that may be incorporated into finished drug products. Heparin Lithium is used in certain medical devices including vacutainer blood collection tubes, some in vitro diagnostic assays, and as a coating for capillary tubes. Celsus has distributed Heparin Sodium USP and Heparin Lithium to manufacturers in both the United States and abroad.

OSCS contaminant in injectable drug products containing heparin has been linked to multiple adverse events and deaths initially reported to the FDA in January 2008. Since then, FDA has put in place a comprehensive inspection and import controls program and has acted to remove from the market heparin materials and products contaminated with OSCS. The seized Celsus heparin--which had entered the United States before the establishment of import controls for the drug--was tested for the presence of OSCS as part of this FDA effort.

The FDA has notified Japanese, Canadian, Australian, European Union, and other international authorities of shipments of contaminated heparin from Celsus.

To date, the agency has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.

Download Center

  • Industrial Premium Library

    Empower your workforce with the manufacturing, industrial maintenance, operations, HSE, compliance, and professional development skills they need to complete their tasks efficiently and safely. Not only will you boost productivity, reliability, skills, and morale but you’ll also onboard faster, and retain your best employees while meeting regulatory standards. Vector Solutions offers over 1,800 award-winning eLearning courses designed to keep your employees safe, transfer knowledge of fundamentals, and develop industry and job-specific skills that reduce downtime, maintenance costs and more.

  • Safety Metrics & Insights Webinar

    EHS professionals have been tackling the subject of how to best measure performance for many years. Lagging indicators like the Total Recordable Incident Rate (TRIR) and Days Away Restricted Transfer Rate (DART) are a good place to start, but you shouldn’t forget about the leading indicators that your workforce does every day to prevent incidents from occurring. Learn about some of the most common KPIs of safety programs and how Vector EHS Management software can be used to track these metrics in this webinar.

  • Risk Matrix Guide

    Understanding the components of a risk matrix will allow you and your organization to manage risk effectively. Download this guide for details on risk matrix calculations including severity, probability, and risk assessment.

  • OSHA Recordkeeping Guide

    In case you missed it, OSHA recently initiated an enforcement program to identify employers who fail to electronically submit Form 300A recordkeeping data to the agency. When it comes to OSHA recordkeeping, there are always questions regarding the requirements and ins and outs. This guide is here to help! We’ll explain reporting, recording, and online reporting requirements in detail.

  • Safety Metrics Guide

    Is your company leveraging its safety data and analytics to maintain a safe workplace? With so much data available, where do you start? This downloadable guide will give you insight on helpful key performance indicators (KPIs) you should track for your safety program

  • Vector Solutions

Featured Whitepaper

OH&S Digital Edition

  • OHS Magazine Digital Edition - September 2022

    September 2022

    Featuring:

    • ESG
      EHS Will Guide Future ESG Success for Many Organizations
    • MACHINE GUARDING
      Handling Material Handlers: Training Beyond PIT Requirements
    • EHS SOFTWARE
      The Missing Link with EHS Software
    • HEARING PROTECTION
      Noise Surveys from the Trenches
    View This Issue