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GSA All Status Vacancies   MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramCompounded Sterile Products by PharMEDium Services: Recall - Lack of Sterility Assurance AUDIENCE: Risk Manager, Pharmacy ISSUE: PharMEDium Services is voluntarily recalling certain lots of drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. See the press release for a listing of affected products. BACKGROUND: PharMEDium conducted a retrospective review of all commercially distributed product lots compounded in the Memphis location currently within their labeled expiration date in response to an FDA request regarding microbial control program during recent inspection to provide verification of acceptable microbiological testing results of the ISO5 environment, personnel glove sampling results, media fill results, sterility testing results, and endotoxin results. The review indicated that a total of 55 lots of different products impacting 25,327 units had two unsuccessful media fills. The remaining lots were associated with environmental monitoring or personnel monitoring excursions in the ISO 5 space on hood/surface and glove tip. Finished product release testing for both sterility and endotoxin were acceptable. Although there were no defects identified in these products, as a conservative measure, a recall is being initiated. The recalled products were distributed nationwide in the USA to hospitals/clinics. RECOMMENDATION: PharMEDium Services is notifying customers of the voluntary recall by phone. Customers that have any of the affected medications that are being recalled should immediately quarantine the product, discontinue use and destroy per their hospital protocol. Customers with any of the affected medications can also reference PharMEDium Services website for more information on the specific lot numbers affected and contact information: www.pharmedium.com.  Patients and healthcare providers with questions regarding this recall can contact PharMEDium Services Clinical Pharmacist at (847) 457-2220, Monday through Friday, between 8am and 5pm Central Standard Time or via e-mail at dantonio@pharmedium.com. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form 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 Read the MedWatch Safety Alert, including a link to the press release, at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm591048.htm T. Marzetti Company Voluntarily Recalls Frozen Biscuit Dough Packed Under Various Brands Due to Potential Listeria Contamination As a precautionary measure, T. Marzetti Company is voluntarily recalling all “Best By” dates of the following products that were distributed in Alabama, Florida, Georgia, Indiana, Kentucky, Louisiana, North Carolina, Pennsylvania, South Carolina, Tennessee, Texas, and Virginia, because they may have the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Consumers should not consume these products.  No illnesses have been reported in connection with the recalled items. PharMEDium Services, LLC Issues Voluntary Nationwide Recall of Certain Lots of Compounded Sterile Products due to Lack of Sterility Assurance PharMEDium Services, LLC (PharMEDium) is voluntarily recalling the below lots of drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, PharMEDium has not received any reports of complaints related to the products but is issuing this recall out of an abundance of caution following a commitment made during a recent inspection of the company’s facility. New Seasons Market Issues Allergy Alert on Undeclared Egg in Packaged Macaroni and Cheese New Seasons Market has initiated a voluntary recall of its New Seasons Market Grab and Go pre-packaged Macaroni and Cheese because it may contain undeclared egg. People who have an allergy or severe sensitivity to eggs run the risk of an allergic reaction if they consume this product. An employee noticed the mislabeled packages during a routine stock rotation check. New Seasons Market Macaroni and Cheese normally contains eggs, but eggs were accidentally left off the ingredients list and the “contains” allergens statement on the label. The recall affects customers who purchasedthe product at New Seasons’ 21 locations in Oregon,Washington and Northern California with Packed On dates between 12/19/2017 and 12/28/2017 and Sell By dates up to 1/02/2018. Reprocessed Agilis Steerable Introducer Sheath by Sterilmed: Class I Recall - Improper Seal of Sheath Hub AUDIENCE: Risk Manager, Cardiology ISSUE: The Agilis Steerable Introducer Sheath’s hemostatic valve, which prevents blood from flowing back through the valve, may fail due to an improper seal of the sheath hub. Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system (air embolism). Model numbers and lot numbers: STJ408309, STJ408310, STJG408324; All product lots Manufacturing and Distribution Dates: January 1, 2017 to May 5, 2017 The use of affected products may cause serious health consequences for patients, including death. BACKGROUND: The Agilis Steerable Introducer Sheath is used to insert and position various cardiovascular catheters in the heart, including on the left side of the heart through the wall of tissue that separates the right and left chambers of the heart (interatrial septum). The improper seal occurs when not enough glue is used to reattach the cap to the hub after reprocessing. Too much glue can also block the sheath valve and make the device unusable. RECOMMENDATION: Sterilmed has provided the following instructions for health care facilities and providers: Examine inventory immediately to determine if you have this product. Do not use any of the affected products, and return any unused product to the company. Share this information with the appropriate staff at your facility. Continue to monitor patients treated with the Sterilmed Reprocessed Agilis Steerable Introducer Sheath as normal. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form 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 Read the MedWatch Safety Alert, including a link to the FDA recall notice, at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm590951.htm FTC Obtains Court Order against Woman Who Allegedly Helped Telemarketers Pitch Phony Money-Making Opportunities and Grants A Utah woman who allegedly helped telemarketers bilk money from consumers is banned from telemarketing, payment processing, and selling grant and business opportunities under a settlement with the Federal Trade Commission. According to the FTC, Jamie L. White enabled telemarketing operations to sell a phony grants program and a worthless moneymaking opportunity purportedly involving customized websites linked to Amazon.com. She supplied consumers with instructions on applying for grants that did not exist, and generic websites that could not generate enough web traffic to provide any of the promised income. In addition, the FTC alleged that White provided the telemarketers with fraudulent merchant accounts to process consumer credit card payments. To accept card payments, a merchant needs an account with a financial institution that is a member of a credit card association such as MasterCard or Visa. In this case, the FTC asserted that the telemarketers could not meet the financial institutions’ standards for opening merchant accounts, so White circumvented the standards by using straw companies to open merchant accounts for the telemarketers. White allegedly forged documents to create fictional financial histories for the straw companies, submitted consumer credit card transactions for processing through the fraudulent accounts, and provided misleading information to financial institutions to dispute consumer complaints about the telemarketers’ worthless offers. The FTC charged White with violating the FTC Act and the FTC’s Telemarketing Sales Rule. Under the settlement order, she is banned from telemarketing, selling grant- and business opportunity-related products and services, and acting as a payment processor, independent sales organization, or sales agent for payment processing services. She is also prohibited from making misrepresentations in selling any product or service, and from profiting from consumers’ personal information collected as part of the challenged practices, and failing to dispose of it properly. The order holds White jointly liable for the judgment of more than $3 million that was entered against Chad Gettel, her associate in the alleged scheme, in September 2017. The judgment is suspended based on her inability to pay. The full judgment will become due immediately if she is found to have misrepresented her financial condition. The FTC thanks the U.S. Attorney’s Office for the District of Utah and the Federal Bureau of Investigation’s Salt Lake City Field Office for their important partnership in this case. White pled guilty to related mail fraud and money-laundering charges brought by the U.S. Attorney’s Office, and is currently awaiting sentencing. The Commission vote authorizing the staff to file the complaint and proposed stipulated final order was 2-0. The U.S. District Court for the District of Arizona entered the order on December 21, 2017. NOTE: The Commission files a complaint when it has “reason to believe” that the law has been or is being violated and it appears to the Commission that a proceeding is in the public interest. Stipulated final orders have the force of law when approved and signed by the District Court judge. The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about consumer topics and file a consumer complaint online or by calling 1-877-FTC-HELP (382-4357). Like the FTC on Facebook, follow us on Twitter, read our blogs and subscribe to press releases for the latest FTC news and resources. Acting FTC Chairman Ohlhausen Names Elder Justice Coordinator to Support Elder Abuse Prevention and Prosecution Act Acting Federal Trade Commission Chairman Maureen K. Ohlhausen has designated Kathleen Benway, Chief of Staff of the Bureau of Consumer Protection, as Elder Justice Coordinator as part of the agency’s responsibilities under the Elder Abuse Prevention and Prosecution Act. The Elder Justice Coordinator is responsible for coordinating and supporting the enforcement and consumer education efforts and policy activities of the FTC on elder justice issues. Under the Act, which is designed to help prevent elder abuse and exploitation and improve the justice system’s response to victims in elder abuse and exploitation cases, the FTC will report annually to the U. S. Senate and House judiciary committees on elder abuse enforcement actions. FTC Gives Final Approval to Lenovo Settlement The Federal Trade Commission has given final approval to a settlement with Lenovo Inc., related to charges that the company harmed consumers by pre-loading software on some laptops that compromised security protections in order to deliver ads to consumers. In its complaint, the FTC charged that beginning in August 2014 Lenovo began selling consumer laptops in the United States that came with a preinstalled advertising software program called VisualDiscovery that interfered with how a user’s browser interacted with websites and created serious security vulnerabilities. As part of the settlement with the FTC, Lenovo is prohibited from misrepresenting any features of software preloaded on laptops that will inject advertising into consumers’ Internet browsing sessions or transmit sensitive consumer information to third parties. If the company preinstalls this type of software, the order requires the company to get consumers’ affirmative consent before the software runs on their laptops. In addition, the company is required for 20 years to implement a comprehensive software security program for most consumer software preloaded on its laptops. The security program will also be subject to third-party audits. The FTC received 10 comments on the settlement. The FTC vote approving the final order as well as responses to the 10 commenters was 2-0.