Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Action
June 25 2009 - 9:09PM
PR Newswire (US)
DETROIT, June 25 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical
Laboratories, Ltd. (NYSE Amex: CPD) announced that U.S. Marshals,
at the request of the Food and Drug Administration, today arrived
and seized drug products manufactured in its Michigan facilities.
The seizure also included ingredients held at these same
facilities. The FDA's most recent inspection of Caraco's Detroit
facility, completed in May 2009, found unresolved violations of
cGMP requirements as previously disclosed in our last SEC filing on
Form 10-K filed June 15, 2009. The Company believes that corrective
actions have been made and continual improvements are in process.
The FDA has only seized products manufactured in its Michigan
facilities. Products distributed by Caraco that are manufactured
outside of these facilities are not impacted. While we have not
fully determined the impact of this action by the FDA on our
financial condition, we believe that it may have a material adverse
effect on our near term operations. We anticipate working with the
FDA to resolve these concerns as effectively and expeditiously as
possible. The Company will provide updates as information becomes
available. Detroit-based Caraco Pharmaceutical Laboratories, Ltd.,
develops, manufactures, markets and distributes generic and
private-label pharmaceuticals to the nation's largest wholesalers,
distributors, drugstore chains and managed care providers. Safe
Harbor: This news release contains forward-looking statements made
pursuant to the safe-harbor provisions of the Private Securities
Litigation Reform Act of 1995. Such statements are based on
management's current expectations and are subject to risks and
uncertainties that could cause actual results to differ materially
from those described in the forward-looking statements. These risks
and uncertainties are contained in the Corporation's filings with
the Securities and Exchange Commission and include, but are not
limited to: information of a preliminary nature that may be subject
to adjustment, potentially not obtaining or delay in obtaining FDA
approval for new products, governmental restrictions on the sale of
certain products, development by competitors of new or superior
products or less expensive products or new technology for the
production of products, the entry into the market of new
competitors, market and customer acceptance and demand for new
pharmaceutical products, availability of raw materials, timing and
success of product development and launches, dependence on few
products generating majority of sales, product liability claims for
which the Company may be inadequately insured, and other risks
identified in this report and from time to time in our periodic
reports and registration statements. These forward-looking
statements represent our judgment as of the date of this report. We
disclaim, however, any intent or obligation to update our
forward-looking statements. DATASOURCE: Caraco Pharmaceutical
Laboratories, Ltd. CONTACT: Daniel Movens, +1-313-871-8400, or
Thomas Versosky, +1-313-556-4150, both of Caraco Pharmaceutical Web
Site: http://www.caraco.com/
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