The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) has released the following information regarding its voluntary recall announced early this morning. The voluntary recall was tied to certain lots of its store brand Acetaminophen 500 mg caplets that contain raw material supplied to the Company from a third party. These caplets may contain trace amounts of metal particulate. The timeline is as follows:
-- The Company's quality control system identified that about one in
400,000 caplets may have contained traces of a metal particulate
substance. The Company confirmed that the majority of the particulates
found were the size of two grains of salt or one millimeter in scope.
The source of the particulates was traced to one of Perrigo's third-
party suppliers.
-- The Company reported the information to the Food and Drug
Administration (FDA) on November 2, 2006.
-- After reviewing the facts and learning of no reports of health
effects, the FDA agreed that the possibility of adverse effects was
remote and began its investigation.
-- The Company has in its possession 100 percent of the initial product
batch that originally caused it to begin its investigation.
-- On November 9, 2006, as a precautionary measure, Perrigo announced a
voluntary retail recall of the product.
-- Perrigo is providing a web-based consumer link for product-specific
data. Visit www.perrigo.com for information.
"Although the FDA agreed that the probability of health risk is remote, and there have been no reports of illness related to this incident, the Company issued a voluntary retail recall to ensure the highest possible product quality standards," said John Hendrickson, EVP and General Manager of Perrigo Consumer Healthcare.
The Perrigo Company is a leading global healthcare supplier and the world's largest manufacturer of over-the-counter (OTC) pharmaceutical and nutritional products for the store brand market. Store brand products are sold by food, drug, mass merchandise, dollar store and club store retailers under their own labels. The Company also develops, manufactures and markets prescription generic drugs, active pharmaceutical ingredients and consumer products, and operates manufacturing facilities in the United States, Israel, United Kingdom, Mexico, Germany and China. Visit Perrigo on the Internet (http://www.perrigo.com/).
Note: Certain statements in this press release 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 particular, statements about the Company's expectations, beliefs, plans, objectives, assumptions or future events or performance contained in this press release are 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 the negative of those terms or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company's control. These and other important factors, including those discussed under "Risk Factors" in the Company's Form 10-K for the year ended July 1, 2006, as well as the Company's subsequent filings with the Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and 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.
First Call Analyst:
FCMN Contact: pblain@perrigo.com
SOURCE: Perrigo Company
CONTACT: Arthur J. Shannon, Vice President, Investor Relations and
Communication, +1-269-686-1709, ajshannon@perrigo.com , or Ernest J. Schenk,
Manager, Investor Relations and Communication, +1-269-673-9212,
eschenk@perrigo.com , both of Perrigo Company
Web site: http://www.perrigo.com/