Navigation Links
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Action

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.

SOURCE Caraco Pharmaceutical Laboratories, Ltd.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Fiscal Year 2009, Updates on FDA Inspection
2. Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Roxicodone(R) Tablets
3. Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Topamax(R) Tablets
4. Caraco Pharmaceutical Laboratories, Ltd. Announces a Nationwide Voluntary Recall of All Lots of Digoxin Tablets Due to Size Variability
5. Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Third Quarter and First Nine Months of Fiscal 2009
6. Caraco Pharmaceutical Laboratories, Ltd. to Announce Third Quarter of Fiscal Year 2009 Results on January 29, 2009
7. Caraco Pharmaceutical Laboratories, Ltd. Responds to FDA Warning Letter
8. Caraco Pharmaceutical Laboratories, Ltd. Update on FDA Warning Letter
9. Caraco Pharmaceutical Laboratories, Ltd. to Market Generic Sinemet(R) Tablets
10. Caraco Pharmaceutical Laboratories, Ltd. Reaches Agreement with Labor Union
11. Caraco Pharmaceutical Laboratories, Ltd. to Market Generic Depakote(R) Delayed Release Tablets
Post Your Comments:
(Date:10/13/2015)... ... October 13, 2015 , ... An increasing number of Florida’s ... has partnered with the Florida Department of Health and its Bureau of Tobacco ... Smoke-Free Multifamily Housing Program launched last week at the organization’s 2015 Annual Conference ...
(Date:10/13/2015)... ... October 13, 2015 , ... ActivePDF, ... new PDF automation tool to batch conversions of CAD drawings, plans, and ... document fidelity. , CADConverter eliminates the complexity requirement of specialized applications to view ...
(Date:10/13/2015)... ... October 13, 2015 , ... ... solutions for drugs, biologics, consumer health and animal health products, today announced that ... lead a new, dedicated global team of drug development and technology experts. , ...
(Date:10/12/2015)... , ... October 13, 2015 , ... North American Tool ... at the 2015 IBC National Meeting in Rosemont, IL on October 4th. ... quality, and standards of excellence that customers have come to expect from members of ...
(Date:10/12/2015)... ... October 12, 2015 , ... Amerec , a leader in ... and skin care equipment, will be displaying custom sauna and steam room solutions at ... high-end resorts and spas as customers, SpaEquip is recognized for their ability to assist ...
Breaking Medicine News(10 mins):
(Date:10/12/2015)... Ga. , Oct. 12, 2015  MiMedx Group, ... company utilizing human amniotic tissue and patent-protected processes to ... Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and ... revenue results for the third quarter of 2015, its ... the Company has secured a $50 million Senior Secured ...
(Date:10/12/2015)... -- This study focuses on China,s ... past decades, the industry has been growing at a fast ... consumer consumptions in China have transformed ... China is one of the world,s major producers ... the world, China is the world,s ...
(Date:10/12/2015)... SACRAMENTO, Calif. , Oct. 12, 2015  In ... month in the Journal of Neurology, Neurosurgery, and Psychiatry, ... to reduce brain atrophy and cognitive decline in patients ... --> --> IVIG, extracted ... contains antibodies to amyloid, an abnormal brain protein found ...
Breaking Medicine Technology: