LAKE ZURICH, Ill.--(BUSINESS WIRE)-- Fresenius Kabi USA announced today it has initiated a voluntary recall of one lot – Lot 6103882 – of Magnesium Sulfate Injection, USP due to the potential presence of glass particles in the vials. The recall is a precautionary measure, following a routine company inspection of retained product samples.
No adverse events, patient reactions or customer complaints have been reported to date. All customers who received the recalled vials are being notified and instructed to return any unused product to their supplier.
The recalled product is labeled with Product Code 6450 and packaged as 500mg/mL strength in 50mL glass vials (25 vials per tray). The product was shipped in the United States between May 30, 2012 and June 6, 2012 and has an expiration date of October 31, 2014.
Magnesium sulfate is used as electrolyte replacement therapy in the treatment of magnesium deficiency, and as an anticonvulsant to prevent and control seizures in severe toxemia of pregnancy.
The administration of glass particulate, if present in a parenteral drug, poses a potential safety risk to patients. Case reports suggest that sequelae of thromboembolism, some life-threatening (such as pulmonary emboli), may occur. There have also been reports in the literature of particulate possibly causing phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a glass particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material and are typically non-serious. The defect discovered in this product lot was noted as visible particulate.
To report adverse events or quality problems experienced with the use of this product, call Fresenius Kabi USA’s Vigilance and Medical Affairs at 1-800-551-7176, Monday through Friday, between the hours of 8 a.m. and 5 p.m. (CST), or by e-mail appmedicalinfo@APPpharma.com.
Adverse events may also 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 MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: 1-800-FDA-0178
Additional Fresenius Kabi contact information
Health care professionals can find additional information about the recall on the company’s web site (www.apppharma.com/our-products/product-updates) or by calling Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, between the hours of 8 a.m. and 5 p.m. (CST).
Questions regarding product availability and ordering can be directed to Fresenius Kabi USA Customer Service at 1-888-386-1300, Monday through Friday, between the hours of 7 a.m. and 6 p.m. (CST).
Fresenius Kabi USA is the U.S. subsidiary of Fresenius Kabi, a global health care company that focuses on medicines and medical devices used to care for critically and chronically ill patients inside and outside the hospital.
Matt KuhnFresenius Kabi1-847-220-3033
Source: Fresenius Kabi USA
Two Respected Companies Unite to Become the Most Comprehensive Industry Supplier of HVAC/R Parts and Equipment
HAUPPAUGE, N.Y.--(BUSINESS WIRE)-- MARS, a leading commercial and residential HVAC/R motors and components supplier, today announced that it has made a strategic acquisition of Heat Controller, Inc., a leading commercial and residential HVAC equipment supplier. As a result of the acquisition, the MARS Company will become the most comprehensive industry supplier of HVAC/R parts and equipment.
According to Edward Chernoff, President and CEO of MARS, the acquisition represents MARS’s commitment to anticipate the needs of the marketplace and proactively invest in creating additional value for the customer. “This acquisition is a merger of equals. Two reputable companies are aligning in order to better serve HVAC/R customers, suppliers, and contractors,” he said. “MARS knows motors and components. Heat Controller knows equipment. The partnership is a natural fit.”
In addition to the inherent synergies between parts and equipment, the acquisition also makes sense from a cultural perspective. Chernoff explained that the companies share similar core values. “The dedication of our people, our unwavering commitment to service, and the quality of our products have made MARS the company it is today,” he said. “Heat Controller shares this same dedication and commitment to quality people, products, and service.”
Although the two business divisions will operate independently under the MARS Company entity, Chernoff says the acquisition lends itself to unlimited opportunities for future collaboration and growth. “Both companies have a rich history of success, as well as extensive HVAC/R industry expertise,” he said. “We look forward to utilizing this combined knowledge and expertise to deliver additional value to our customers.”
Don Peck, CEO of Heat Controller, agrees. “These are exciting times for Heat Controller, and we believe the merger into the MARS family will be a perfect fit going forward,” he said. “Heat Controller will continue to operate from Jackson, Michigan, and Guelph, Ontario, with the same dedicated employees and management. Our goal is to make this transition transparent to our customers and to continue to serve them as we have in the past.”
Founded in 1946, Motors and Armatures (d.b.a. MARS) is a family-owned and operated supplier of quality motors, components, and service/installation parts for the HVAC/R industry. The company distributes its own extensive MARS and JARD branded aftermarket replacement products, as well as the original equipment components of leading manufacturers. MARS is headquartered in Hauppauge, NY, and operates distribution facilities in Earth City, MO, and Mississauga, Canada.
About Heat Controller, Inc.
For more than 75 years, Heat Controller, Inc. has earned its reputation as THE SOURCE for residential and commercial heating, cooling, and dehumidification equipment. The company markets its products under the Comfort‐Aire and Century brand names in the United States and under the Comfort‐Aire by Aiton’s brand name in Canada.
CHICAGO, May 25, 2013 (GLOBE NEWSWIRE) -- As Memorial Day weekend kicks-off, Country music superstar Tim McGraw teamed up with Outback Steakhouse® and Operation Homefront to surprise ten families from across the country that have a long family history of military service at a lunch at a local Outback in Chicago. Surprise guest, McGraw, thanked the families for their dedication to the military while guests from all generations shared their personal stories about a family member that inspired them to serve. The event was part of Outback's ongoing support of the military and their families.
Multimedia accompanying this release is available at http://www.globenewswire.com/mpr/outback-steakhouse/10034100.html
"It is always an honor to spend time with our armed forces, and it was a privilege to be part of today's lunch at Outback Steakhouse," said Tim McGraw. "Like all of our honorees today, I come from a military family with multiple generations who have served, and I understand the commitment, dedication and sacrifice it takes to serve our country."
Operation Homefront, the national non-profit that provides emergency financial and other assistance to the families of our service members and wounded veterans, worked with Outback to identify active and retired service members and invited them to Chicago for a special experience to pay tribute to their families' service. The honorees knew they'd be treated to lunch, but McGraw's appearance was a surprise. The military service members who attended the event along with their families included:
- Isa McIntyre- Bethesda, MD
- James Van Thach- Bellerose Manor, NY
- John Wiernasz- Spooner, WI
- Thomas English- Williamston, MI
- Michael Welch- Yankton, SD
- Linda Brashears- Romeoville, IL
- Mitchell Nihart- Elkhart, IN
- Sonja Martin- Highland Park, IL
- Scott Williams- Channahon, IL
- Kyle Radke- Elgin, IL
"As we take time this Memorial Day to remember those who've given their lives in service to our nation, we also wanted to honor families who have a long-standing history of military service," said Outback Steakhouse Chief Marketing Officer, Mike Kappitt. "Outback Steakhouse is dedicated to supporting our troops and Operation Homefront's mission, and we were excited to work with our friend, Tim McGraw, to help organize this special event for these inspiring military families."
As part of its on-going commitment to supporting U.S. military personnel, Outback Steakhouse will continue to honor our heroes with a Military Mates 10% off discount Memorial Day – July 4th, 2013.
"We are thrilled to be involved in this unique event that honor military families with generations of selfless service members," said Amy Palmer, Chief Programs and Field Operations Officer for Operation Homefront. "Outback Steakhouse and Tim McGraw have been great partners who share our commitment to the troops, and we're always happy to have an opportunity to work together in support of our armed services."
Outback began its partnership with Operation Homefront more than three years ago to enhance its support to our nation's troops. Since 2010, Outback has donated over two million dollars to support Operation Homefront.
About Outback Steakhouse
Outback Steakhouse was voted #1 Best Steak in the 2012 Zagat Survey® of National Full-Service Restaurant Chains for the third consecutive year. Outback Steakhouse starts fresh every day to create the flavors that our mates crave. Best known for grilled steaks, chicken and seafood, Outback also offers a wide variety of crisp salads and freshly made soups and sides. New creations and grilled classics are made from scratch daily using only the highest quality ingredients sourced from around the world. For more information, please visit www.outback.com or http://www.facebook.com/outback.
About Operation Homefront
A national nonprofit, Operation Homefront leads more than 6,500 volunteers with nationwide presence who provide emergency and other financial assistance to the families of service members and wounded warriors. Operation Homefront has met more than 741,000 needs of military families since its inception in 2002. A four-star rated charity by watchdog Charity Navigator, nationally, 94 percent of total revenue donated to Operation Homefront goes directly to programs that provide support to our military families. For more information, go to www.OperationHomefront.net.
CONTACT: Lisa Bain MSLGROUP (646) 500 - 7723 Lisa.Bain@mslgroup.com
PITTSBURGH, May 25, 2013 (GLOBE NEWSWIRE) -- Pittsburgh Corning Corporation, (www.pghcorning.com) a global manufacturer of sustainable, high performance glass products for the building, energy and industrial markets, announced that its Modified Third Amended Plan of Reorganization was confirmed by the U.S. Bankruptcy Court for the Western District of Pennsylvania, effective late yesterday. The confirmation leads the company one step closer to emerging from Chapter 11 bankruptcy. Pittsburgh Corning has operated under Chapter 11 protection since April 16, 2000.
Between 1964 and 1972, Pittsburgh Corning manufactured, marketed and sold Unibestos, an asbestos pipe insulation product it acquired from Union Asbestos and Rubber Company. The company manufactured Unibestos at its plants in Tyler, Texas and Port Allegany, Pennsylvania. While the Pittsburgh Corning revenues for this product averaged less than $3 million annually, the company was named as a defendant in asbestos-related lawsuits, defending and resolving more than 200,000 claims. Pittsburgh Corning sought Chapter 11 protection in 2000, when it became apparent that defending and settling an additional 235,000 claims would exhaust company resources before they could be resolved.
The newly confirmed Plan of Reorganization establishes a trust valued in excess of $3.5 billion to assume all asbestos-related liabilities and resolve all asbestos personal injury claims. The trust will be funded by Pittsburgh Corning, its shareholders PPG Industries Inc. and Corning Incorporated, and participating insurance carriers.
"The trust is intended to help support the people and families who were harmed by asbestos," said Phillip M. Martineau, Chairman and CEO of Pittsburgh Corning. The confirmation of the Plan paves the way for the next step in the process: review and affirmation of the Plan by the U.S. District Court for the Western District of Pennsylvania.
"Pittsburgh Corning is making progress. While the legal work continues and our lengthy Chapter 11 process is not yet fully concluded, the confirmation of our Plan of Reorganization is a turning point, leading us closer to the consummation of the Chapter 11 proceedings," said Martineau. "We thank our customers and our employees, shareholders, suppliers and business partners, whose loyalty has been instrumental in keeping Pittsburgh Corning stable and competitive during the past 13 years. Their dedication has allowed the Company to continue providing premium products and support services. Pittsburgh Corning today has built a strong foundation for continued growth, and we look forward to our final emergence from bankruptcy."
About Pittsburgh Corning Corporation
Pittsburgh Corning Corporation is a global leader in the design and manufacture of specialized insulation and glass block for building and industrial applications. Headquartered in Pittsburgh, Pennsylvania, the company is an equity affiliate of PPG Industries, Inc. and Corning, Inc.
The Pittsburgh Corning FOAMGLAS® business manufactures high-performance FOAMGLAS® cellular glass insulation used in industrial, commercial and building applications. FOAMGLAS® insulation offers a unique combination of properties, making it one of the highest performing insulation materials available. Billions of feet of FOAMGLAS® have been installed throughout the world in thousands of buildings and industrial plants. Pittsburgh Corning Corporation also offers a full line of complementary accessory products including sealants, adhesives, and jacketing.
The Pittsburgh Corning glass block business is the largest United States manufacturer of premium glass block products and specialized architectural window systems for commercial, institutional, government and residential buildings.
CONTACT: MEDIA CONTACT: Jeannine F. Addams or Kristin Wohlleben J. Addams & Partners, Inc. 404.231.1132 office 912-258-0794 cell email@example.com firstname.lastname@example.org
/PRNewswire-USNewswire/ -- The thousands of Postal Service employees who have individually driven more than a million, accident-free miles are delivering safety tips to Americans hitting the road this Memorial Day weekend.
WASHINGTON , May 24, 2013
- Drive defensively — expect the unexpected.
- Maintain a safe distance of one car length for every 10 mph between you and the car in front of you.
- Be courteous, use turn signals and obey all laws.
- Keep your options open — have a "what to do if I'm cut off" strategy.
- Turn off mobile devices when driving — no cell phones or texting.
How do they do it?
"Safe driving is no accident," said U.S. Postal Service Safety and Health Director Linda DeCarlo. "The safety of our employees is our top priority, and we are proud our comprehensive safe driver training program is second to none."
According to the National Safety Council, more than 9,300 Postal Service employees have achieved a distinction most people never approach in their lifetimes — driving more than a million, accident-free miles. No other business comes close.
The nation's 31,000 plus Post Offices are linked by nearly 214,000 vehicles — the world's largest civilian fleet. More than 300,000 letter carriers and truck drivers log more than 1.2 billion miles annually when delivering to America's 151.5 million addresses.
Since 2005, 9,385 Postal Service professionals have each driven more than a million miles without a single accident. Reaching this pinnacle requires a safe attitude that entails driving 1 million miles or 30 years without a preventable incident.
Tips from a few Million Milers
- For Orchard Park, NY, City Carrier Nancy Pillard, with almost 34 years on the job, safety starts before she even takes to the streets. "I make sure my vehicle is in complete operative condition every day," she said. "I identify and report repair work for lights, tires, wipers and mirrors, and I then make sure that the repairs are done ASAP."
- Akron, OH, Five Points Station Letter Carrier Pat Betts has driven nearly 35 years without a motor vehicle accident. "I've learned to slow down with my driving as I have senior citizens on my route and businesses that generate a lot of traffic," said Betts. "I use my turn signals — even in parking lots which are inherently unsafe."
- Orchard Park, NY Letter Carrier Ron Reukauf started his postal career in 1978, but also has a few years of personal driving under his seat belt. More than 40 years of driving experience has provided him with some sound practices and wisdom. "I've found myself adopting three theories on safety which have helped me so far," said Reukauf. "They are: 'Expect the unexpected;' 'Any distraction can put you in traction;' and 'Safety first, never last. Have a future, not a past."
- Norway, SC, Rural Carrier, Dwain Fogle has driven 33 years with a perfect driving safety record — just like his father. Bryan Fogle, Dwain's dad, delivered mail in Neeses and Orangeburg, SC, during his 41-year career. He earned the award before retiring in 1998. Dwain delivers to 452 mail boxes along 92.5 miles of highway and 35 miles of dirt roads in his right-hand drive jeep. Dwain credits his dad with teaching him to be respectful of others. "I was taught as a child to be courteous. I think being courteous to each other is the main thing when you're on the road," he said.
Safe Driving Habits Start With Good Training
Driving for the Postal Service is a privilege. All drivers must demonstrate safe-driving practices throughout their careers. Behind-the-wheel job candidates undergo a rigorous screening, training and certification process to earn credentials to operate a right-hand drive postal vehicle.
After a review of state driving records, candidates undergo a thorough medical examination and an extensive interview process. They then take a web-based 4-hour defensive driving training course, followed by a 1-hour defensive driving debrief conducted by driver safety instructors who reinforce key safe-driving topics covered in the web-based course.
Candidates then become familiar with the vehicle through behind-the-wheel training on a mock driving course. The skills course acclimates candidates to driving postal vehicles under various conditions on an 'off-road' course that simulates street conditions. Their performance is evaluated on a final drive prior to becoming certified to operate Postal Service vehicles.
Information on the National Safety Council's Safe Driver Program is located at www.nsc.org/usps. Questions can be directed to National Safety Council Customer Relations at 1-800-621-7619 or email@example.com.
The Postal Service receives no tax dollars for operating expenses, and relies on the sale of postage, products and services to fund its operations.
A self-supporting government enterprise, the U.S. Postal Service is the only delivery service that reaches every address in the nation: 152 million residences, businesses and Post Office Boxes. The Postal Service receives no tax dollars for operating expenses and relies on the sale of postage, products and services to fund its operations. With more than 31,000 retail locations and the most frequently visited website in the federal government, usps.com, the Postal Service has annual revenue of more than $65 billion and delivers nearly 40 percent of the world's mail. If it were a private-sector company, the U.S. Postal Service would rank 42nd in the 2012 Fortune 500. The Postal Service has been named the Most Trusted Government Agency for seven years and the fourth Most Trusted Business in the nation by the Ponemon Institute.
SOURCE U.S. Postal Service
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