Leiner Health Products Submits Proposed Agreement with Department of Justice to U.S....

Leiner Health Products Submits Proposed Agreement with Department of Justice
to U.S. Bankruptcy Court for Approval
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 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.

Jen Brown, of Weber Shandwick for Leiner Health Products Inc.,
+1-212-445-8469