Hyundai is recalling 188,000 Sonatas manufactured between 2011 and 2014 due to safety issues involving the gearshift cable. Many lives have been saved due to the efforts of trial lawyers in product liability cases through the years leading to improvements in the car industry. However, this is why we continue to evaluate even one vehicle wrecks involving serious injury or death to determine if defects in the automobile contributed in causing the wreck or injury.
Our teachers and administrators do a great job with what they have to work with. But the NAEP's latest national assessment show Alabama fourth and eighth graders average scores below the national average in all subjects. Eighth graders rank 50th in math. We don't settle for less than number one in football in this state. Should we settle for less in education? Direct Result: More crime and less high paying jobs. Ask your legislators and the Governor to fund education. Our children deserve a better future.
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Bristol-Myers Squibb Issues Voluntary Nationwide Recall of COUMADIN® (Warfarin Sodium) for Injection Due to Presence of Particulate Matter
Contact:
Consumer:
1-800-332-2056
Media:
Laura Hortas
609-252-4587
laura.hortas@bms.com
Ken Dominski
609-252-5251
ken.dominski@bms.com
FOR IMMEDIATE RELEASE - June 30, 2014 – NEW YORK – Bristol-Myers Squibb Companydisclaimer icon (NYSE:BMY) is voluntarily recalling six lots of COUMADIN® FOR INJECTION, 5 mg single-use vials in the U.S. This recall is a precautionary measure based on the company's investigation of visible particulate matter found in a small number of COUMADIN FOR INJECTION unreleased samples. Bristol-Myers Squibb believes the safety risk to patients is low, and is further mitigated by the product's prescribing information advising that intravenous drug products be inspected visually prior to administration.
Injected particulate metallic and non-metallic cellulose material can cause serious and potentially fatal adverse reactions such as embolization. Allergic reactions to the foreign material could also occur. To date, there have been no product complaints or adverse events reported to Bristol-Myers Squibb related to this issue.
COUMADIN FOR INJECTION was discontinued in early April 2014. The oral formulation, Coumadin tablets, is not impacted by this recall.
COUMADIN FOR INJECTION is a prescription medicine used to treat blood clots and to lower the chance of blood clots forming in the body. COUMADIN FOR INJECTION is typically administered in a hospital setting by health care professionals to patients not able to receive the oral formulation.
COUMADIN FOR INJECTION 5 mg single-use vials is packaged in cartons of six vials. The affected COUMADIN FOR INJECTION includes the following six lots distributed to hospitals and pharmacies from November 2011 through January 2014:
Lot Number Description NDC Expiration
00201125 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Sep-2014
00201126 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Nov-2014
00201127 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Dec-2014
00201228 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Jun-2015
00201229 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Jul-2015
00201230 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Sep-2015
Bristol-Myers Squibb has issued recall communications to health care professionals and other customers involved and is arranging for return of all recalled products. Anyone that has COUMADIN FOR INJECTION which is being recalled should stop use and distribution and contact Bristol-Myers Squibb’s recall vendor, GENCO, at 1-855-838-5784 to arrange for return of remaining stock.
Health care professionals and patients may call the following number for assistance if they have further questions about the recall:
General and Medical Inquiries:
Bristol-Myers Squibb Customer Information Center 1-800-332-2056
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm disclaimer icon
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm disclaimer icon or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
COUMADIN® (warfarin sodium) Prescribing Informationdisclaimer icon (PDF: 172 KB)
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.comdisclaimer icon or follow us on Twitter at http://twitter.com/bmsnewsdisclaimer icon.
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Date:
Sunday, July 6, 2014
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Troopers say a single-vehicle crash Sunday, has claimed the life of a Calera man.
According to a press release around 7:27 p.m., 30-year-old Justin McDowell was killed when the 2006 Mercedes Benz he was driving left the roadway and overturned.
The crash occurred on U.S. 80 at the 100 mile marker, one mile east of Dallas County.
No other details are being released at this time as the investigation continues.
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