Recent Blog Posts

CHECK OUT THIS BABY

Lucas — Wed, 19 Jun 2013 01:00:00 GMT

This Bentley could be yours ... for a mere $210,000.

(Comes with a seat massager and seat "cooler" -- which you'll need after the massage.)

GET THE BEST FROM YOUR CHICKS

Lucas — Wed, 19 Jun 2013 00:45:00 GMT

An interesting book for sale at Lowe's, Staten Island

Photo credit: Gines Pasamonte

REMEMBERING SALLY'S RIDE

Lucas — Wed, 19 Jun 2013 00:30:00 GMT

First American Woman in Space

On June 18, 1983, Sally Ride became the first American woman to fly in space when the space shuttle Challenger launched on mission STS-7.

As one of the three mission specialists on the STS-7 mission, she played a vital role in helping the crew deploy communications satellites, conduct experiments and make use of the first Shuttle Pallet Satellite. In this image, Dr. Ride sits in the aft flight deck mission specialist's seat during deorbit preparations.

› Read more about Sally Ride's historic flight.

Image Credit: NASA

HERBST HOSTS ROSADO

Lucas — Wed, 19 Jun 2013 00:00:00 GMT

Leonard Herbst is hosting a cocktail reception for Mary V. Rosado, candidate for New York City Civil Court Judge,

on Thursday, June 20, 2013, from 6-9 PM.

Event particulars have been deleted. For additional information, please call 917-279-6520.

BE A MAN

Lucas — Tue, 18 Jun 2013 23:30:00 GMT

Man up

Take the Next Step
Preventive Care

From the U.S. Department of Health and Human Services, I’m Nicholas Garlow with HHS HealthBeat.

Minority men face certain health challenges. Black men have a high risk of dying from heart disease. Latino men are diagnosed with AIDS three times as often as white men. But men can do things that can protect their health. Most health plans cover recommended preventive services like screenings at no cost under the health care law.

Dr. J. Nadine Gracia is HHS’ deputy assistant secretary for minority health.

“Screenings for blood pressure, blood sugar and cholesterol and HIV, are some of the main tests that will let you know if you’re still on the path toward great health.”

Taking your health into your own hands also means eating right, being active, and talking about your health with your loved ones.

“It’s important to know your family health history, so you can create a plan with your health care provider.”

Learn more at healthfinder.gov.

HHS HealthBeat is production of the U.S. Department of Health and Human Services. I’m Nicholas Garlow.

WILSON ELSER HOSTS NETWORKING BREAKFAST

Lucas — Tue, 18 Jun 2013 23:00:00 GMT

Networking Breakfast

followed by a Special Presentation

Legal Considerations for E-commerce and Website Promotion

What every website operator needs to know about utilizing a website in its business, including steps to take when operating an interactive site or a blog; domain name registration and protection; use of others' trademarks and copyrights; what terms of use and sale may be needed; required privacy policies; data security and privacy protection; online advertising and promotions; contests and sweepstakes; online fundraising; and defamation risks.

Tuesday, June 25th

8:30am- 9:15am (Networking)

9:30am Presentation

Wilson Elser

150 East 42^nd Street (Between 3rd & Lex.)

New York, NY 10017

About Wilson Elser

Wilson Elser, a full-service and leading defense litigation law firm (www.wilsonelser.com), serves its clients with nearly 800 attorneys in 24 offices in the United States and one in London, and through a network of affiliates in key regions globally. Founded in 1978, it ranks among the top 200 law firms identified by The American Lawyer and is included in the top 50 of The National Law Journal's survey of the nation's largest law firms. Wilson Elser serves a growing, loyal base of clients with innovative thinking and an in-depth understanding of their respective businesses.

Seating is limited-breakfast will be served

Members $10.00

Guests $20.00

go to www.ny-chamber.com

LIMITING ALIEN SUITS

Lucas — Tue, 18 Jun 2013 22:30:00 GMT

Impact of Kiobel v. Royal Dutch Petroleum on the Alien Tort

Wednesday, June 26, 2013, 6:30 PM- 8:00 PM
There is no charge for this program.

Add To Outlook

Where:

42 West 44th Street
New York, NY 10036

The Alien Tort Statute ("ATS") has been used as a jurisdictional basis for foreign plaintiffs to sue multinational corporations in U.S. courts over their alleged violations of international law. In April 2013, the United States Supreme Court, in Kiobel v. Royal Dutch Petroleum Co., issued a ruling limiting the extraterritorial application of the ATS. The Court's decision continues a recent trend by federal courts of invoking the presumption against the extraterritorial application of U.S. laws.

The panel, composed of members of the ATS plaintiffs' bar, defense bar, and academia, will discuss and debate the scope of the Kiobel holding and the future of the ATS litigation and other U.S. litigation.

Moderators: HAGIT ELUL, Hughes Hubbard & Reed LLP; SANDER BAK, Milbank Tweed Hadley & McCloy LLP

Speakers: MARTIN FLAHERTY, Leitner Family Professor; Co-Director, Leitner Center for International Law and Justice, Fordham Law School; CAREY R. D’AVINO, Eaton & Van Winkle LLP; co-counsel for Plaintiff; OWEN C. PELL, White & Case LLP and counsel for amicus Cato Institute

Sponsored by: Committee on Federal Courts, Marilyn Kunstler, Chair

CRIMINAL USE OF BACKGROUND CHECKS

Lucas — Tue, 18 Jun 2013 22:00:00 GMT

EEOC Files Suit Against Two Employers for Use of Criminal Background Checks

BMW Fired and Denied Hire to Class of Employees Who Worked Successfully for Years; Dollar General Disproportionately Excluded African Americans From Hire

A BMW manufacturing facility in South Carolina, and the largest small-box discount retailer in the United States violated Title VII of the Civil Rights Act by implementing and utilizing a criminal background policy that resulted in employees being fired and others being screened out for employment, the U.S. Equal Employment Opportunity Commission alleged in two recently filed lawsuits.

The EEOC's Charlotte district office filed suit in U.S. District Court of South Carolina, Spartanburg Division against BMW Manufacturing Co., LLC, and a separate suit was filed in Chicago against Dolgencorp, doing business as Dollar General.

In the suit against BMW, the EEOC alleges that BMW disproportionately screened out African Americans from jobs, and that the policy is not job related and consistent with business necessity. The claimants were employees of UTi Integrated Logistics, Inc. ("UTi"), which provided logistic services to BMW at the South Carolina facility. The logistics services included warehouse and distribution assistance, transportation services and manufacturing support.

Since 1994, BMW has had a criminal conviction policy that denies facility access to BMW employees and employees of contractors with certain criminal convictions. However, when UTi assigned the claimants to work at the BMW facility, UTi screened the employees according to UTi's criminal conviction policy. UTi's criminal background check limited review to convictions within the prior seven years. BMW's policy has no time limit with regard to convictions. The policy is a blanket exclusion without any individualized assessment of the nature and gravity of the crimes, the ages of the convictions, or the nature of the claimants' respective positions.

In 2008, UTi ended its contract with BMW. During a transitional period, UTi employees were informed of the need to re-apply with the new contractor to retain their positions in the BMW warehouse. As part of the application process, BMW directed the new contractor to perform new criminal background checks on every current UTi employee applying for transition of employment. The new contractor subsequently discovered that several UTi employees had criminal convictions in violation of BMW's criminal conviction policy. As a result, those employees were told that they no longer met the criteria for working at the BMW facility and were subsequently terminated and denied rehire as employees of the new contractor, despite the fact that many of the employees had worked at the BMW facility for years.

In Illinois, the Chicago office of the EEOC filed a nationwide lawsuit based on discrimination charges filed by two rejected black applicants. That lawsuit charges that Dollar General conditions all of its job offers on criminal background checks, which results in a disparate impact against blacks. Dollar General operates 10,000 stores in 40 states, plus 11 distribution centers. Ninety percent of all Dollar General employees are store clerks who are both stockers and cashiers at the stores.

According to the EEOC, one of the applicants who had filed a charge with EEOC was given a conditional employment offer, although she had disclosed a six-year-old conviction for possession of a controlled substance. Her application also showed that she had previously worked for another discount retailer as a cashier-stocker for four years. Nevertheless, her job offer was allegedly revoked because Dollar General's practice was to use her type of conviction as a disqualification factor for 10 years.

The other applicant who filed an EEOC charge was fired by Dollar General although, according to the EEOC, the conviction records check report about her was wrong - she did not have the felony conviction attributed to her. The EEOC said that although she advised the Dollar General store manager of the mistake in the report, the company did not reverse its decision and her firing stood.

"Title VII of the Civil Rights Act of 1964 prohibits discrimination against job applicants and employees on account of their race," said EEOC Chair Jacqueline A. Berrien. "Since issuing its first written policy guidance in the 1980s regarding the use of arrest and conviction records in employment decisions, the EEOC has advised employers that under certain circumstances, their use of that information to deny employment opportunities could be at odds with Title VII."

"The Commission is committed to using public education and informal resolution to address discriminatory hiring practices," said David Lopez, EEOC General Counsel. "When these methods are unsuccessful, the Commission will, if necessary, seek redress from the federal courts and ensure equal opportunity for all. This is the latest in a series of systemic cases the Commission has filed to challenge unlawful hiring practices."

Both lawsuits were brought under Title VII of the Civil Rights Act of 1964, which prohibits discrimination on the basis of race and national origin as well as retaliation. The EEOC will assert claims of disparate impact, in both cases, against African Americans. The EEOC filed suit in each instance after attempting to resolve the matter through settlement. In all, the Commission will seek back pay, as well as injunctive relief to prevent future discrimination of employees and applicants.

Eliminating barriers in recruitment and hiring, especially class-based recruitment and hiring practices that discriminate against racial, ethnic and religious groups, older workers, women, and people with disabilities, is one of six national priorities identified by the Commission's Strategic Enforcement Plan (SEP).

On April 25, 2012, the EEOC issued updated enforcement guidance on employer use of arrest and conviction records. The EEOC is a member of the federal interagency Reentry Council, a Cabinet-level interagency group convened to examine all aspects of reentry of individuals with criminal records. Among other issues, the Reentry Council is working to reduce barriers to employment, so that people with past criminal involvement - after they have been held accountable and paid their dues - can compete for appropriate work opportunities in order to support themselves and their families, pay their taxes, and contribute to the economy.

The EEOC enforces the federal laws prohibiting employment discrimination. More information about the EEOC is available on its website, www.eeoc.gov.

"CLEAN HEAT" WEBINAR

Lucas — Tue, 18 Jun 2013 21:30:00 GMT

Con Ed Area Growth Zones Webinar on Wednesday, June 19th

As the result of the City's ongoing phase-out of #6 oil, many buildings owners are converting either to gas or to #2 or #4 oil. In an effort to expand natural gas availability in New York City, Con Ed has identified 12 Area Growth Zones for possible expansion of gas service. Buildings within these zones may be eligible to connect at no cost for firm gas service with one point of entry to each building's property line.

NYC Clean Heat will be holding a webinar to discuss the 2014 plan on Wednesday June 19th at 12:00pm. Owners must RSVP to info@nyccleanheat.org.

Videos on the basic information about clean heat and Area Growth Zones are available at http://bit.ly/11WKK4f. Owners can also contact NYC Clean Heat at info@nyccleanheat.org to determine if their buildings are within a 2014 Growth Zone. Simply include a list of your buildings in the email and they can assist you. In addition, NYC Clean Heat can be reached at 212-656-9202.

Information is also available from Con Ed at www.coned.com/gasconversions

PUTTING LAWYERS ON THE SPOT IN FORECLOSURE CASES

Lucas — Tue, 18 Jun 2013 21:15:00 GMT

New Yorkers Sink Deeper into Debt & Could Lose Homes Because of Foreclosure Lawyers' Stall Tactics

Nearly 25,000 New Yorkers are at risk of losing their homes because some bank lawyers are exploiting an administrative loophole that is stalling foreclosure lawsuits. New Yorkers are waiting nearly three years on average for foreclosure cases brought against them to be resolved. Meantime, they're facing mounting interest and penalties every month, making it harder for them to afford a mortgage modification.

Click here to write a Letter to the Editor on this issue.

But there is a common-sense solution.

Proposed legislation (S4530/A5582-A) would require bank lawyers to certify the legitimacy of their cases when they file the lawsuit, guaranteeing each case will get into the court system and the homeowner will get to mediation within 60 days. This would allow homeowners to work out affordable mortgage modifications with the bank.

State Attorney General Eric Schneiderman, the court system and Senate co-leader Jeff Klein all support the bill, which passed the Assembly last month with support from both Democrats and Republicans. The Senate should pass this bill too and send it to Governor Cuomo before lawmakers leave Albany for the year later this month.

We encourage you to write a Letter to the Editor to express your thoughts on this common-sense legislation that could help thousands of New Yorkers who are at risk of losing their homes.

SOME PEOPLE ARE OUT OF THEIR MINES

Lucas — Tue, 18 Jun 2013 21:00:00 GMT

TSA Week in Review: 43 Firearms, an Inert Claymore Mine, and More

Loaded Firearm (ATL)

43 Firearms Discovered This Week –Of the 43 firearms, 36 were loaded and 13 had rounds chambered. See a complete list and more photos at the bottom of this post.

Inert Claymore Mine and Grenade (SJC)

Inert Ordnance and Grenades etc. - We continue to find inert hand grenades and other weaponry on a weekly basis. Please keep in mind that if an item looks like a realistic bomb, grenade, mine, etc., it is prohibited - real or not. When these items are found at a checkpoint or in checked baggage, they can cause significant delays in checkpoint screening. I know they are cool novelty items, but you cannot bring them on a plane. Read here and here on why inert items cause problems.

Grenades Discovered at (L-R) MGM, ROC, CRP, LAS

An inert Claymore mine was discovered in a checked bag at San Jose (SJC).
Two inert M60 timed blasting fuses were discovered in checked baggage at Savannah (SAV).
Five inert/novelty/replica grenades were discovered this week. Three were in carry-on bags at Las Vegas (LAS), Corpus Christi (CRP), and Montgomery (MGM). Two were discovered in checked baggage at Rochester (ROC), and San Jose (SJC).

Inert M60 Timed Blasting Fuses (SAV)

Stun Guns – 11 stun guns were discovered this week in carry-on bags around the nation: Two were discovered at San Diego (SAN), and the others were found at Birmingham (BHM), Denver (DEN), Grand Rapids (GRR), Jacksonville (JAX), Las Vegas (LAS), Los Angeles (LAX), Reno (RNO), San Juan (SJU), and Sacramento (SMF).

Stun Guns Discovered at (L-R) LAX, DEN, JAX, LAS

Starter Pistol (BUF)

On your mark, get set, stop! – A starter pistol was discovered in a carry-on bag at Buffalo (BUF).

Bang Stick (KOA)

Bang Stick - A .44 caliber bang stick was detected in the carry-on bag of a Kona (KOA) passenger. For anyone who uses these, please note that they are prohibited in carry-on bags.

Items in the Strangest Places –It's important to examine your bags prior to traveling to ensure no prohibited items are inside. If a prohibited item is discovered in your bag, you could be cited and quite possibly arrested by local law enforcement. Here are a few examples from this week where prohibited items were found in strange places.

Knife in Hard Drive (BHM) - Razorblade in Shoe (HNL)

Three cane swords were discovered this week. Two were discovered at Los Angeles (LAX), and the other at Long Beach (LGB).
A multi tool was discovered concealed inside of a computer hard drive at Birmingham (BHM).
A razorblade was discovered concealed in the shoe of a Honolulu (HNL) passenger.
Pepper spray designed to look like a lipstick case was discovered in Phoenix (PHX).
A small knife was discovered in a shoe at Dallas/Fort Worth (DFW).

Sword Canes Discovered at (Top to Bottom) LAX, LGB, LAX

What Not to Say at an Airport – Statements like these not only delay the people who said them but can also inconvenience many other passengers if the checkpoint or terminal has to be evacuated:

After alarming advanced imaging technology, a Houston (HOU) passenger stated: "I am packing a bomb." She wasn't.

Knives Discovered at (L-R) EWR, SJC, LAX, EWR, LGB

Pepper Spray Lipstick (PHX)

Miscellaneous Prohibited Items - In addition to all of the other prohibited items we find weekly, our Officers also regularly find firearm components, realistic replica firearms, bb and pellet guns, Airsoft guns, brass knuckles, ammunition, batons, and a lot of sharp pointy things…

Firearms Discovered This Week in Carry-On Bags

Discovered at (L-R) FLL, ATL, AUS, BNA, IAD, LAX, PVD, FAT

Discovered at (L-R) HOU, JAX, MIA, JAX, SDF

Discovered at (L-R) BWI, ATL, AUS, DAL, DEN, TLH, DEN

Discovered at (L-R) CHO, TUL, LAS

Discovered at (L-R) ABQ, TPA, AUS, FAY, LAX, TPA

You can travel with your firearms in checked baggage, but they must first be declared to the airline. You can go here for more details on how to properly travel with your firearms. Firearm possession laws vary by state and locality. Travelers should familiarize themselves with state and local firearm laws for each point of travel prior to departure.

Unfortunately these sorts of occurrences are all too frequent which is why we talk about these finds. Sure, it's great to share the things that our officers are finding, but at the same time, each time we find a dangerous item, the throughput is slowed down and a passenger that likely had no ill intent ends up with a citation or in some cases is even arrested. The passenger can face a penalty as high as $7,500.00. This is a friendly reminder to please leave these items at home. Just because we find a prohibited item on an individual does not mean they had bad intentions, that's for the law enforcement officer to decide. In many cases, people simply forgot they had these items.

*In order to provide a timely weekly update, I compile my data from a preliminary report. The year-end numbers will vary slightly (increase) from what I report in the weekly updates. However, any monthly, midyear, or end-of-year numbers TSA provides on this blog or elsewhere will not be estimates.

If you haven't seen it yet, make sure you check out our post highlighting the dangerous, scary, and downright unusual items our officers found in 2012. The 2011 list can be found here.

Bob Burns

TSA Blog Team

XGEVA

Lucas — Tue, 18 Jun 2013 20:30:00 GMT

FDA approves Xgeva to treat giant cell tumor of the bone

The U.S. Food and Drug Administration today expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor.

GCTB generally occurs in adults between the ages of 20 and 40 years. In most cases, GCTB does not spread to other parts of the body but destroys normal bone as it grows, causing pain, limited range of motion and bone fractures. Rarely, GCTB can transform into a cancerous tumor and spread to the lungs.

Xgeva is a monoclonal antibody that binds to RANKL, a protein essential for maintenance of healthy bone. RANKL is also present in GCTB. Xgeva is intended for patients whose GCTB cannot be surgically removed (unresectable) or when surgery is likely to result in severe morbidity, such as loss of limbs or joint removal. It should only be used in adolescents whose bones have matured.

“Today’s approval of Xgeva provides a needed treatment option for patients with GCTB who are not surgical candidates or who would otherwise have to undergo extensive, life-altering surgery,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research.

The FDA reviewed Xgeva under its priority review program, which provides for an expedited review of drugs. Xgeva was granted orphan product designation because it is intended to treat a rare disease or condition.

The safety and effectiveness of Xgeva for GCTB were established in two clinical trials that enrolled a total of 305 adult or adolescent patients. All patients had confirmed cases of GCTB that were recurrent, unresectable or where surgery would result in severe morbidity.

Of the 187 patients whose tumors could be measured, 47 patients had their tumors reduce in size after an average of three months. Over an average follow-up duration of 20 months, re-growth of GCTB occurred in three patients whose tumors originally became smaller during treatment.

Common side effects included joint pain (arthralgia), headache, nausea, fatigue, back pain and extremity pain. The most common serious side effects were osteonecrosis (areas of dead bone) of the jaw and osteomyelitis (inflammation or infection of the bone). Women of reproductive potential should use highly effective contraception while taking Xgeva because of potential fetal harm.

Xgeva was approved in 2010 to prevent fractures when cancer has spread to the bones. It is marketed by Amgen, based in Thousand Oaks, Calif.

For more information:

FDA: Office of Hematology and Oncology Products

FDA: Approved Drugs: Questions and Answers

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

AN INTERNSHIP FOR YOUNG ADULTS

lucas — Tue, 18 Jun 2013 20:15:00 GMT

Young Adult Internship Program (YAIP)

The Young Adult Internship Program (YAIP) is a 14-week workforce development internship program. YAIP targets young adults ages 16-24, who are not working and not in school. YAIP begins with a two- to four-week orientation, conducted by DYCD-funded community-based organizations (CBOs), and followed by a 10- to 12-week paid internship that offers structured work opportunities incorporating ongoing education, as well as additional participant and employer support.

For more information, visit www.nyc.gov/dycd or call DYCD Youth Connect at 1-800-246-4646.

ON LIFTING DEPRESSION

Lucas — Tue, 18 Jun 2013 20:00:00 GMT

Scan predicts whether therapy or meds will best lift depression

Biomarker could point the way past trial-and-error inefficiencies

Pre-treatment scans of brain activity predicted whether depressed patients would best achieve remission with an antidepressant medication or psychotherapy, in a study funded by the National Institutes of Health.

If a patient’s pre-treatment resting brain activity was low in the front part of the insula, on the right side of the brain (red area where green lines converge), it signaled a significantly higher likelihood of remission with CBT and a poor response to escitalopram. Conversely, hyperactivity in the insula predicted remission with escitalopram and a poor response to CBT. Picture shows PET data superimposed on anatomic MRI scan data. Source: Helen Mayberg, M.D, Emory University

“Our goal is to develop reliable biomarkers that match an individual patient to the treatment option most likely to be successful, while also avoidingthose that will be ineffective,” explained Helen Mayberg, M.D., of Emory University, Atlanta, a grantee of the NIH’s National Institute of Mental Health.

Mayberg and colleagues report on their findings in JAMA Psychiatry, June 12, 2013.

“For the treatment of mental disorders, brain imaging remains primarily a research tool, yet these results demonstrate how it may be on the cusp of aiding in clinical decision-making,” said NIMH Director Thomas R. Insel, M.D.

Currently, determining whether a particular patient with depression would best respond to psychotherapy or medication is based on trial and error. In the absence of any objective guidance that could predict improvement, clinicians typically try a treatment that they, or the patient, prefer for a month or two to see if it works. Consequently, only about 40 percent of patients achieve remission following initial treatment. This is costly in terms of human suffering as well as health care spending.

Mayberg’s team hoped to identify a biomarker that could predict which type of treatment a patient would benefit from based on the state of his or her brain. Using a positron emission tomography (PET) scanner, they imaged pre-treatment resting brain activity in 63 depressed patients. PET pinpoints what parts of the brain are active at any given moment by tracing the destinations of a radioactively-tagged form of glucose, the sugar that fuels its metabolism.

They compared brain circuit activity of patients who achieved remission following treatment with those who did not improve.

Activity in one specific brain area emerged as a pivotal predictor of outcomes from two standard forms of depression treatment: cognitive behavior therapy (CBT) or escitalopram, a serotonin specific reuptake inhibitor (SSRI) antidepressant. If a patient’s pre-treatment resting brain activity was low in the front part of an area called the insula, on the right side of the brain, it signaled a significantly higher likelihood of remission with CBT and a poor response to escitalopram. Conversely, hyperactivity in the insula predicted remission with escitalopram and a poor response to CBT.

Among several sites of brain activity related to outcome, activity in the anterior insula best predicted response and non-response to both treatments. The anterior insula is known to be important in regulating emotional states, self-awareness, decision-making and other thinking tasks. Changes in insula activity have been observed in studies of various depression treatments, including medication, mindfulness training, vagal nerve stimulation and deep brain stimulation.

Emory clinical neuroscientists study brain scans in effort to find better ways to help patients recover from depression.

“If these findings are confirmed in follow-up replication studies, scans of anterior insula activity could become clinically useful to guide more effective initial treatment decisions, offering a first step towards personalized medicine measures in the treatment of major depression” said Mayberg.

Grant number: 5 R01 MH073719 04

The mission of the NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery and cure. For more information, visit http://www.nimh.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

BE WARFARIN WARY

Lucas — Tue, 18 Jun 2013 19:30:00 GMT

Zydus Pharmaceuticals USA Inc. Issues Voluntary Nationwide Recall of Warfarin 2 mg Tablets, Lot MM5767, Expiration Date June 2014, Due to Oversized Tablets

Zydus Pharmaceuticals USA Inc. is voluntarily recalling one lot of Warfarin 2 mg Tablets, Lot #MM5767, expiration date June 2014 to the retail level. Four tablets of Warfarin 2 mg Tablets, Lot MM5767, have been found to be oversized in one product complaint.

Ingestion of a greater than intended dose of Warfarin, could lead to an increased pharmacological effect of warfarin. As a result, patients would be more likely to develop bleeding as an adverse reaction and in some patients that bleeding into a critical organ (mostly the central nervous system) could be fatal. The risk of bleeding is increased if overdosing is repeated continuously on a daily basis.

Zydus has not received any reports of adverse events or any additional product complaint related to this lot to date, but as a precautionary measure, Zydus is recalling lot MM5767 from the distribution.

The product is used as prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE), prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement and reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. Product is packaged in HDPE Bottle of 1000's count, which may have been dispensed to patients in smaller bottles. The only lot affected of Warfarin 2 mg Tablets being recalled is Lot MM5767.

The product can be identified by its NDC #6838205310. The product was distributed nationwide in the United States to wholesalers/distributors, retailers and mail order providers, from November 2012 to December 2012.

Zydus has notified its direct account customers by sending the recall notification letter by FedEx next day air service and is working with customers to arrange for product return.

Anyone with an existing inventory of this particular Lot MM5767 of Warfarin 2 mg Tablets should stop use and distribution, quarantine the recalled lots immediately and call INMAR at 1-800-967-5952 between the hours of 7 a.m. to 4 p.m. CST, Monday through Friday, to arrange for their return. In case patients have tablets of this lot of product, make sure all the tablets are of same size and if unsure, patients should consult their dispensing pharmacy.

If you have any question about product safety issue, then please call Zydus Pharmaceuticals Drug Safety/ Medical Affairs at 1-877-993-8779, Option# 2. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this particular lot of Warfarin 2 mg Tablets.

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.

Online: www.fda.gov/medwatch/report.htm
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at:
www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.