FDA Warns of Compounding Pharmacy's Products

The agency recommended that Park Compounding Pharmacy cease sterile operations and recall all non-expired sterile drug products; the company agreed to halt sterile operations but not to the recall.

FDA announced that its investigators observed insanitary conditions, including poor sterile production practices, during a recent inspection of Park Compounding Pharmacy's facility, saying this raised concerns about the company's ability to assure the sterility of drug products that it produced. So the agency has issued a warning to alert health care professionals and patients not to use drug products intended to be sterile made and distributed by Chen Shwezin Inc., doing business as Park Compounding Pharmacy, in Westlake Village, Calif.

FDA on Sept. 29 recommended that Park Compounding Pharmacy cease sterile operations until adequate corrections are made and recall all of its non-expired sterile drug products. On Sept. 30, the company "informed FDA that it has agreed to cease sterile operations, but the company has refused to recall its products," according to the FDA, which reported it is not aware of any adverse event associated with the use of products from Park Compounding Pharmacy.

Patients who have received drug products produced by Park Compounding Pharmacy and have concerns about them should contact their health care professional, according to the agency, which recommends that health care professionals immediately check their medical supplies, quarantine any sterile drug products from Park Compounding Pharmacy, and not administer them to patients.

FDA's MedWatch safety alert is available here.

Download Center

  • The Ultimate Guide to OSHA Recordkeeping

    When it comes to OSHA recordkeeping, there are always questions regarding the requirements and in and outs. This guide is here to help!

  • Lone Worker Safety Guide

    As organizations digitalize and remote operations become more commonplace, the number of lone workers is on the rise. These employees are at increased risk for unaddressed workplace accidents or emergencies. This guide was created to help employers better understand common lone worker risks and solutions for lone worker risk mitigation and incident prevention.

  • Online Safety Training Buyer's Guide

    Thinking of getting an online safety training solution at work but not sure how to evaluate different solutions and find the one that's best for your company? Use this handy buyer's guide to learn the basics of selecting online safety training and how to use it at your workplace.

  • SDS Software Buyer's Guide

    Whether this is your first time shopping for online SDS software or you’re upgrading from a legacy solution, this guide is designed for you to use in your search for the safety management solution that works best for you and your company.

  • Risk Matrix Guide

    Risk matrices come in many different shapes and sizes. Understanding the components of a risk matrix will allow you and your organization to manage risk effectively.

  • Vector Solutions

OH&S Digital Edition

  • OHS Magazine Digital Edition - November December 2021

    November December 2021

    Featuring:

    • GAS DETECTION
      How to Streamline Gas Detector Maintenance
    • OSHA TOP 10
      OSHA's Top 10 Most Frequently Cited Standards for FY 2021
    • PROTECTIVE APPAREL
      How PPE Can Help You Deal with the Harsh Condition of Winter
    • HEARING PROTECTION
      Tackling Hearing Protection in the Workplace
    View This Issue