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ETHEX Corporation Initiated Nationwide Voluntary Recall of a Single Lot of Hydromorphone HCl 2 mg Tablets Due to Potential for Oversized Tablet

December 23, 2008

ST. LOUIS, Dec. 23 /PRNewswire/ — ETHEX Corporation announced today that
it has voluntarily recalled to the consumer level, a single production lot of
Hydromorphone HCl 2 mg tablets (Lot #90219, Exp: 03/2010; NDC #58177-0620-04),
as a precaution, due to the possibility it may contain oversized tablets.
Hydromorphone is a drug used for pain management and is packaged under the
ETHEX label in 100-count bottles.

If someone were to take a higher than expected dose of Hydromorphone, the
risk of adverse effects known to be associated with the drug may be increased,
including respiratory depression (difficulty or lack of breathing), low blood
pressure, and sedation.

There are other companies in the United States producing and marketing
versions of Hydromorphone HCl tablets and consumers and their caregivers are
encouraged to check their prescriptions to determine the source of their
tablets. Hydromorphone HCl 2 mg tablets marketed by ETHEX are a blue, round
tablet with a script “E” on one side and a “2″ on the other side.

ETHEX Corporation has initiated recall notifications to wholesalers and
retailers nationwide who have received any inventory of the recalled lot of
this product with instructions for returning the recalled product and, if they
have not already done so, they are urged to contact ETHEX as provided below
regarding procedures for returning the recalled product. If consumers have
any questions about the recall, they should call the telephone number below or
their physician, pharmacist, or other health care provider.

Any customer inquiries related to this action should be addressed to ETHEX
Customer Service at 1-800-748-1472 or fax to ETHEX Customer Service at
314-646-3751, or e-mail to customer-service@ethex.com. Representatives are
available Monday through Friday, 8 am to 5 pm CST. Consumers who experience
any adverse reactions to this drug should contact their physician and/or
healthcare provider immediately. Any adverse reactions experienced with the
use of this product, and/or quality problems may also be reported to the FDA’s
MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail
at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the
MedWatch website at http://www.fda.gov/medwatch.

The Hydromorphone HCl recall announcement is posted on
http://www.kvpharmaceutical.com and http://www.fda.gov/opacom/7alerts.html.
It includes step-by-step details on how to return affected product to KV
Pharmaceutical. The Company web site also includes a list of the drugs
affected by the suspension.

The parent company of ETHEX Corporation, KV Pharmaceutical (NYSE: KV-A),
has advised the U.S. Food and Drug Administration that, effective midnight
Dec. 19, 2008, the company voluntarily suspended shipments of all FDA-approved
drug products in tablet form. This action is being taken as a precautionary
measure, to allow KV to expeditiously address manufacturing issues that have
come to management’s attention, to review and enhance comprehensively the
company’s quality systems, and to implement efficiency improvements in its
production facilities. KV is keeping the FDA informed about the Company’s
plans.

This recall and suspension are being conducted with the knowledge of the
FDA. At this time, the company is unable to determine when distribution of
tablet form products will resume, or estimate what the financial impact of the
recall and suspension will be.

Safe Harbor

ETHEX Corporation is a wholly owned subsidiary of KV Pharmaceutical
Company, which we refer to as “KV” or the “Company”. The information in this
release may contain various forward-looking statements within the meaning of
the United States Private Securities Litigation Reform Act of 1995 (“PSLRA”)
and which may be based on or include assumptions concerning KV’s operations,
future results and prospects. Such statements may be identified by the use of
words like “plans”, “expect”, “aim”, “believe”, “projects”, “anticipates”,
“commit”, “intend”, “estimate”, “will”, “should”, “could” and other
expressions that indicate future events and trends.

All statements that address expectations or projections about the future,
including without limitation, product development, product launches,
regulatory approvals, market position, acquisitions, revenues, expenditures
and other financial results, are forward-looking statements.

All forward-looking statements are based on current expectations and are
subject to risk and uncertainties. In connection with the “safe harbor”
provisions, KV provides the following cautionary statements identifying
important economic, political and technology factors, which among others,
could cause actual results or events to differ materially from those set forth
or implied by the forward-looking statements and related assumptions.

Such factors include (but are not limited to) the following: (1) changes
in the current and future business environment, including interest rates and
capital and consumer spending; (2) the difficulty of predicting FDA approvals,
including timing, and that any period of exclusivity may not be realized; (3)
acceptance and demand for new pharmaceutical products; (4) the introduction
and impact of competitive products and pricing, including as a result of
so-called authorized-generic drugs; (5) new product development and launch,
including the possibility that any product launch may be delayed or that
product acceptance may be less than anticipated; (6) reliance on key strategic
alliances; (7) the availability of raw materials and/or products manufactured
for the Company under contract manufacturing arrangements with third parties;
(8) the regulatory environment, including regulatory agency and judicial
actions and changes in applicable law or regulations; (9) fluctuations in
revenues; (10) the difficulty of predicting international regulatory approval,
including timing; (11) the difficulty of predicting the pattern of inventory
movements by the Company’s customers; (12) the impact of competitive response
to the Company’s sales, marketing and strategic efforts, including the
introduction or potential introduction of generic or competing products
against products sold by the Company and its subsidiaries; (13) risks that the
Company may not ultimately prevail in litigation, including challenges to our
intellectual property rights by actual or potential competitors or to our
ability to market generic products due to brand company patents and challenges
to other companies’ introduction or potential introduction of generic or
competing products by third parties against products sold by the Company or
its subsidiaries including without limitation the litigation and claims
referred to in Note 16 of the Notes to the Consolidated Financial Statements
in the Company’s Form 10-Q for the quarter ended June 30, 2008; (14) the
possibility that KV’s current estimates of the financial effect of certain
announced product recalls could prove to be incorrect; (15) whether any
product recalls or product introductions results in litigation, agency action
or material damages; (16) the possibility that the findings of the Audit
Committee inquiry referenced in the Company’s Form 10-Q for the quarter ended
June 30, 2008, and Form 12b-25 filed with the SEC on November 13, 2008, could
have a material impact on the Company’s financial results; (17) whether any
suspension of shipments could have a material affect on the Company’s
financial results; (18) the satisfaction or waiver of the other closing
conditions in the previously disclosed Gestiva(TM) acquisition agreement; (19)
the possibility that the auction rate securities held by the Company may not
return to liquidity or at their face value; and (20) the risks detailed from
time-to-time in the Company’s filings with the Securities and Exchange
Commission. This discussion is by no means exhaustive, but is designed to
highlight important factors that may impact the Company’s outlook. We are
under no obligation to update any of the forward-looking statements after the
date of this release.

SOURCE ETHEX Corporation


Source: newswire



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