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:2/10/2016)... AZ (PRWEB) , ... February 10, 2016 , ... Ongoing ... the Aging Life Care Association™ (ALCA) to conduct a survey that takes a closer ... experts released today illustrates the prevalence and causes of TBI among the aging population, ...
(Date:2/10/2016)... (PRWEB) , ... February 10, 2016 , ... AxoGen, Inc. ... will report results for the fourth quarter and full year ended December 31, 2015 ... a conference call and webcast for the investment community following the release at 4:30 ...
(Date:2/10/2016)... ... ... For additional information contact Phyllis Strupp 480-488-5858 , Brain improves with age, ... Guide to Brain Training" by award-winning author Phyllis Strupp explains how brain ... 16, 2016. A free review copy is available to the media at NetGalley ...
(Date:2/10/2016)... ... February 10, 2016 , ... IDEX Health & Science, LLC ... steel (PLS) columns combine the strength of traditional stainless steel with the chemical ... samples while operating at ultra-high pressures of 20,000 psi. The higher operating pressures ...
(Date:2/10/2016)... , ... February 10, 2016 , ... The recreational use ... enthusiasts in the state still face a lot of restrictions as to where they ... intended for private, personal use” and that cannabis “may not be consumed openly or ...
Breaking Medicine News(10 mins):
(Date:2/9/2016)... REDWOOD CITY, Calif. , Feb. 9, 2016 /PRNewswire/ ... medical device company that is providing innovative evidence-based solutions ... it will release financial results for the fourth quarter ... Monday, February 29, 2016. Company management will host a ... p.m. Eastern Time) on Monday, February 29, 2016. ...
(Date:2/9/2016)... Feb. 9, 2016  Insulet Corporation (NASDAQ: PODD ) ... pump technology with its OmniPod ® ... has been appointed to Insulet,s Board of Directors. With ... eight of whom are independent. --> ... audit and finance experience and a deep knowledge of accounting, ...
(Date:2/9/2016)... 9, 2016 QGEN ... den Abschluss eines Kooperationsvertrags mit 10x Genomics ... in den Bereichen Next-Generation-Sequencing (NGS), Single-Cell-Biology und ... Frankfurt Prime Standard: QIA) gab heute den ... die Entwicklung und Förderung umfassender Lösungen in ...
Breaking Medicine Technology: