Navigation Links
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Action
Date:6/25/2009

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:
*Name:
*Comment:
*Email:
(Date:4/26/2017)... ... April 26, 2017 , ... RawTrition now brings you BioEnergy which ... nutrients from SUPERFOODS! , RawTrition is taking nutrients to the next level! ... the body recognizes its raw form (unlike the synthetically made options that are on ...
(Date:4/26/2017)... ... April 26, 2017 , ... MYOLYN, a medical technology company ... has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for ... Both devices are stationary cycling systems that use MYOLYN’s patent-pending functional electrical ...
(Date:4/25/2017)... ... April 25, 2017 , ... ... committed to raising awareness for Duchenne muscular dystrophy, and funding for Duchenne ... (cardiosphere-derived cells) Phase I/II HOPE clinical trial in Duchenne announced today. , ...
(Date:4/25/2017)... ... April 25, 2017 , ... The doctors at Wall Centre Dental ... with dental fear and require sedation to receive dental care. The doctors offer three ... procedures, from hygienic cleanings to oral surgery, at their dental office in Vancouver. Wall ...
(Date:4/25/2017)... ... April 25, 2017 , ... ... in unveiling cutting-edge birth defects research related to Zika virus during pregnancy, as ... premier society for this important science. , The Teratology Society ...
Breaking Medicine News(10 mins):
(Date:4/19/2017)... 2017  Novartis today announced the publication of ... and Blood Institute (NHLBI) of the National Institutes ... with treatment-naïve severe aplastic anemia (SAA) achieved complete ... at the initiation of and concurrently with standard ... sequential treatment groups, or cohorts. Cohort 3 added ...
(Date:4/18/2017)... DUBLIN, Ohio , April 18, 2017  Cardinal ... its Non-GAAP 1 fiscal 2017 earnings per share ... 2018 and 2019.  This is in conjunction with this ... Care, Deep Vein Thrombosis and Nutritional Insufficiency businesses. ... EPS from continuing operations will be at the bottom ...
(Date:4/18/2017)... Viverae ® , a leader in workplace wellness technology, ... Watson Campaign Automation, implementing behavioral messaging within the ... experience. Through digital engagement, the platform prompts members to ... The enhanced experience drives engagement by focusing on the ... in their journey to health. Unlike ...
Breaking Medicine Technology: