UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported):
November 23, 2004
PERRIGO COMPANY
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(Exact name of registrant as specified in its charter)
MICHIGAN 0-19725 38-2799573
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(State of other (Commission (IRS Employer
Jurisdiction of File Number) Identification No.)
Incorporation)
515 Eastern Avenue, Allegan, Michigan 49010
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (269) 673-8451
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Not Applicable
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(Former name or 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:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange
Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange
Act (17 CFR 240.13e-4(c))
ITEM 8.01. Other Events
Product Recall
The Company has initiated a retail-level recall of all lots of loratadine syrup,
a liquid antihistamine indicated for the relief of symptoms due to hay fever or
other upper respiratory allergies.
During post-marketing stability studies, the Company detected a difference in
the stability profiles of the batches used to support FDA approval and the
batches initially manufactured. The Company has made the decision to recall all
product from the retailer and wholesaler channels. An independent medical
consultant has indicated that there is "no indication that this would result in
any patient toxicity or negative effects". The subject recall is not safety
related. There have been no reports of injury or illness related to the use
of this product.
The value of the Company's on-hand inventories and the cost of return and
disposal is estimated to be between $7.5 and $8.5 million, which is expected to
reduce earnings $0.07 to $0.08 per share for the fiscal second quarter ending
December 25, 2004. In addition, the impact of not having the product available
for sale will reduce earnings no more than an additional $0.02 in the second
half of fiscal year 2005.
Certain statements in this 8-K are forward-looking statements within the meaning
of Section 21E of the Securities Exchange Act of 1934, as amended, and are
subject to the safe harbor created thereby. These statements relate to future
events or the Company's future financial performance and involve known and
unknown risks, uncertainties and other factors that may cause the actual
results, levels of activity, performance or achievements of the Company or its
industry to be materially different from those expressed or implied by any
forward-looking statements. In some cases, forward-looking statements can be
identified by terminology such as "may," "will," "could," "would," "should,"
"expect," "plan," "anticipate," "intend," "believe," "estimate," "predict,"
"potential" or other comparable terminology. Please see the "Cautionary Note
Regarding Forward-Looking Statements" on pages 27 - 33 of the Company's Form
10-K for the year ended June 26, 2004 for a discussion of certain important
factors that relate to forward-looking statements contained in this press
release. Although the Company believes that the expectations reflected in these
forward-looking statements are reasonable, it can give no assurance that such
expectations will prove to be correct. Unless otherwise required by applicable
securities laws, the Company disclaims any intention or obligation to update or
revise any forward-looking statements, whether as a result of new information,
future events or otherwise.
SIGNATURES
Pursuant to the requirement of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
PERRIGO COMPANY
(Registrant)
Dated: November 24, 2004 By: /s/ Douglas R. Schrank
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Douglas R. Schrank
Executive Vice President and
Chief Financial Officer
(Principal Accounting and Financial Officer)