U.S. Marshals Seize Caraco Pharmaceutical Laboratories Drugs

U.S. Marshals, at the request of the Food and Drug Administration, have seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company's Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities.

"The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Compliance with these standards prevents harm to the public."

This action follows Caraco's continued failure to meet the FDA's current Good Manufacturing Practice (cGMP) requirements, which assure the quality of manufactured drugs. Through this seizure, the FDA seeks to immediately stop the firm from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements.

Since January 2009, Caraco has initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets, and possible formulation error.

FDA has determined that the seizure of Caraco's drugs may create a shortage of one product, choline magnesium trisalicylate oral tablets, which are commonly used as pain relievers. FDA recommends in the event of a shortage, that health care providers consider alternative treatments that are safe and effective. Consumers and health care providers who are unable to obtain any of Caraco's products should contact the FDA Drug Shortage Program by e-mail at [email protected], or by telephone at 888-463-6332 or 301-796-3400.

To view questions and answers on Caraco Drugs, click here.

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