Navigation Links
Leiner Health Products Submits Proposed Agreement with Department of Justice to U.S. Bankruptcy Court for Approval
Date:5/9/2008

Resolves Allegations of Compliance Matters at Defunct Facility

CARSON, Calif., May 9 /PRNewswire/ -- Leiner Health Products Inc. ("Leiner" or "the Company") announced today that it has submitted a proposed agreement with the United States Department of Justice to the U.S. Bankruptcy Court in Delaware for approval. The proposed agreement would resolve the previously disclosed investigation concerning the production, control and distribution of certain over-the-counter (OTC) drug products at the Company's now defunct Fort Mill, South Carolina facility. The agreement is subject to approval and acceptance by the United States District Court in Columbia, South Carolina.

This agreement would resolve the government's investigation of allegations against Leiner, which were related to a previously disclosed Form 483 report the Company received from the Food and Drug Administration (FDA) on March 16, 2007. Both the investigation and the Form 483 pertained to activities that took place at the now closed Fort Mill facility prior to the arrival of the current Quality Control management team.

"Leiner took immediate action to correct this situation," said Robert K. Reynolds, CEO and President of Leiner. "In addition to the closure of the affected facility, we also restructured our Quality Control systems, including top to bottom personnel changes and implementation of strengthened compliance programs to ensure that all products conform to Leiner's rigorous standards."

Under the terms of the agreement, Leiner Health Products, LLC, a subsidiary of Leiner Health Products Inc., would enter a plea of guilty to one count of mail fraud and would forfeit $10 million in cash in lieu of a fine. The agreement in no way implicates or affects Leiner's ability to manufacture and distribute vitamin and mineral products.

Mr. Reynolds continued, "We are pleased to put these issues behind us, and we are committed to providing consumers with the best value and highest- quality products available in the marketplace."

As previously announced on March 10, 2008, Leiner filed voluntary petitions for relief under Chapter 11 of the U.S. Bankruptcy Code in Delaware in order to continue its operations and enhance the value of its business. The proposed agreement requires approval by, and has been submitted to the Bankruptcy Court in Delaware.

Additional information on the Chapter 11 process can be obtained from the Company's website at http://www.leinerinformation.com or by calling 1-888-264-1304.

About Leiner Health

Founded in 1973 and headquartered in Carson, Calif., Leiner Health Products is America's leading manufacturer of store brand vitamins, minerals, and nutritional supplements (VMS), as measured by retail sales, and supplies the food, drug, mass merchant and warehouse club (FDMC) retail market. Leiner provides the leading FDMC retailers with over 2,000 products to help its customers create and market high-quality store brands at low prices. It is also the largest supplier of VMS to the U.S. military. Leiner markets its own brand of vitamins under YourLife(R). In 2007, Leiner distributed more than 21 billion doses that help offer consumers high quality, affordable choices to improve their health and wellness.

Media Contact:

Jen Brown, Weber Shandwick

(212) 445-8469


'/>"/>
SOURCE Leiner Health Products Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Breathe Technologies, Inc. Closes on $15 Million in Venture Funding Led by Kleiner Perkins Caufield & Byers
2. Penn study finds pro-death proteins required to regulate healthy immune function
3. UCLA researchers identify markers that may predict diabetes in still-healthy people
4. Air pollution linked to cardiovascular risk indices in healthy young adults
5. More proof needed of safety and quality of electronic personal health records
6. Health care incentive model offers collaborative approach
7. Loneliness is bad for your health
8. Mailman School of Public Health study examines link between racial discrimination and substance use
9. Green Tea May Brew Up Healthier Skin
10. For Health Info, Women Often Turn to the Web
11. Record Number of Americans Lack Health Insurance
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, ... Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. ... skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... recover from injury. Recently, he has implemented orthobiologic procedures as a method for ... is one of the first doctors to perform the treatment. Orthobiologics are substances ...
(Date:6/24/2016)... Marne, Michigan (PRWEB) , ... June 24, 2016 , ... ... awareness about the dangers associated with chronic pain and the benefits of holistic treatments, ... for individuals who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA ... the Road To Recovery® program to drive cancer patients to and from their cancer ... ensure the highest quality of life and ongoing independence. Getting to and from ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® & Innovative ... has initiated cultivation and processing operations at its production facility, and opened its ... Puradigm is the manufacturer of a complete system of proactive air and surface ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 Any dentist who ... challenges of the current process. Many of them do not ... the technical difficulties and high laboratory costs involved. And those ... offer it at such a high cost that the majority ... Dr. Parsa Zadeh , founder of Dental ...
(Date:6/23/2016)... , June 23, 2016 ... CAPR ), a biotechnology company focused on ... today announced that patient enrollment in its ongoing ... Duchenne) has exceeded 50% of its 24-patient target. ... in the third quarter of 2016, and to ...
(Date:6/23/2016)... 23, 2016  Astellas today announced the establishment of Astellas Farma Colombia (AFC), a new affiliate with operations headquartered ... Latin America . ... ... ... ...
Breaking Medicine Technology: