FDA, Federal Agents Seize $24.2 Million in Unapproved New Drugs

Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service yesterday seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical.

The seizure followed an inspection of several of the company's plants where FDA investigators found that the company was not complying with an FDA enforcement notice, as well as manufacturing unapproved new drugs such as products for coughs, colds, topical wound healing, skin bleaching, and gastrointestinal conditions, as well as narcotic drug products.

"The FDA is committed to taking enforcement action against firms that circumvent the drug approval process," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research. "Consumers need to be confident that the drugs and medical products they use are safe and effective, and the FDA will take the necessary measures to ensure safety and effectiveness throughout the lifecycle of the product, including keeping the product from reaching the marketplace."

In a routine inspection of KV Pharmaceutical's facilities in early 2008, FDA found the company was violating its May 29, 2007, notice (72 FR 29517) requiring companies to stop manufacturing all timed-release drug products containing guaifenesin, including combination drug products in which guaifenesin is in immediate release form, but another ingredient in the combination drug product is in timed-release form, because they are unapproved new drugs.

FDA took the action as part of its effort to ensure that all drugs marketed in the United States have the required FDA approval and that they are safe, effective, of good quality, and are appropriately labeled. For products in timed-release form, FDA approval is also necessary to make sure that the product releases its active ingredients at the correct rate. Improperly manufactured timed-release products may release the active ingredients too quickly, too slowly, or not at all, making the product unsafe or ineffective.

FDA required companies to stop manufacturing the affected products before Aug. 27, 2007, and to stop shipping the products before Nov. 26, 2007. KV Pharmaceutical continued to manufacture and ship these unapproved new drugs after the cessation dates.

The inspection also exposed the company's manufacturing and distribution of other unapproved drug products. The following drug products were seized and will be destroyed: PhenaVent Capsules, PhenaVent LA Capsules, PhenaVent PED Capsules, Ethezyme Papain-Urea Ointment, Ethezyme 650 Papain-Urea Ointment, Ethezyme 830 Papain-Urea Ointment, Hista-Vent DA Tablets, Meperidine/Promethazine Capsules, Pseudovent Capsules, Pseudovent 400 Capsules, Pseudovent PED Capsules, Tri-Vent DM Syrup, Tri-Vent DPC Syrup, Hydro-Tussin DM Liquid, Hydro-Tussin CBX Syrup, Hydro-Tussin DHC Syrup, Hydro- Tussin EXP Syrup, Hydro-Tussin HD Syrup, Hyoscyamine Sulfate Sublingual Tablets, Hydroquinone 4% Cream, Hydroquinone 4% Cream with Sunscreen, Bromfenex Extended Release Capsules, and Bromfenex PD Extended Release Capsules.

The seized drugs had been held under embargo by the state of Missouri. Since the time of the embargo, KV Pharmaceutical has been cooperating with FDA officials.

Download Center

HTML - No Current Item Deck
  • Safety Management Software - Free Demo

    IndustrySafe Safety Software’s comprehensive suite of modules help organizations to record and manage incidents, inspections, hazards, behavior based safety observations, and much more. Improve safety with an easy to use tool for tracking, notifying and reporting on key safety data.

  • Create Flexible Safety Dashboards

    IndustrySafe’s Dashboard Module allows organizations allows you to easily create and view safety KPIs to help you make informed business decisions. Our best of breed default indicators can also save you valuable time and effort in monitoring safety metrics.

  • Schedule and Record Observations

    IndustrySafe's Observations module allows managers, supervisors, and employees to conduct observations on employees involved in safety critical behavior. IndustrySafe’s pre-built BBS checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Why Is Near Miss Reporting Important?

    A near miss is an accident that's waiting to happen. Learn how to investigate these close calls and prevent more serious incidents from occurring in the future.

  • Get the Ultimate Guide to Safety Training

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We’ve put together a guide on key safety training topics, requirements for certifications, and answers to common FAQs.

  • Industry Safe
comments powered by Disqus

OH&S Digital Edition

  • OHS Magazine Digital Edition - June 2019

    June 2019

    Featuring:

    • ASSP SAFETY 2019 PREVIEW
      New Orleans Networking
    • NATION SAFETY MONTH
      Heed These Summer Safety Tips
    • TRAINING
      Education, Skill Development, and Behavior Change
    • SAFETY MANAGEMENT
      What Good Looks Like
    View This Issue

Bulwark Quiz