UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
Current Report
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
LEINER HEALTH PRODUCTS INC.
(Exact name of registrant as specified in its charter)
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DELAWARE
(State or other
jurisdiction of
incorporation or
organization)
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333-33121
(Commission File Number)
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95-3431709
(IRS Employer
Identification
Number) |
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901 East 233rd Street, Carson, California
(Address of principal executive offices)
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90745
(Zip Code) |
Registrant’s telephone number, including area code
(310) 835-8400
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of
the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
TABLE OF CONTENTS
Item 8.01 Other Events.
On
September 5, 2007, Leiner Health Products Inc. (the
“Company”) became aware of a Department
of Justice investigation relating to the production, control, and distribution of certain
over-the-counter (
“OTC”) drug products at
the Company’s Fort Mill Facility.
The Company believes
that the investigation concerns certain activities relating to the observations included in a Form
483 report it received from the Food and Drug Administration (
“FDA”).
The Company intends to
cooperate fully with this investigation.
As previously reported,
the Company received a Form 483 report on
March 16, 2007 relating to
its OTC drug operations in
the Company’s Fort Mill facility.
The Company suspended production and
distribution of its OTC products in all of its locations on
March 20, 2007. Additionally the
Company recalled all of its OTC products in April 2007 and hired third-party independent
consultants to help implement appropriate corrective action.
The FDA has reaffirmed that it will stand behind its commitments and will continue to work
with
the Company as
the Company prepares to reenter the OTC marketplace.
The Company believes that
its decisions and voluntary actions subsequent to receipt of the Form 483 report are evidence of
the highest level of commitment on its part to address all issues raised in the Form 483 report.
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