U.S.A.'s interesting latest

Setton International Foods Issues Allergy Alert for Undeclared Milk in Select Dark Chocolate Almonds and Dark Chocolate Raisins Products Received from our Supplier GKI Foods LLC Setton International Foods, Inc. of Commack, NY, is voluntarily recalling select dark chocolate almonds and dark chocolate raisins products. All these products contain undeclared Milk. People with an allergy or severe sensitivity to milk run the risk of a serious or life threatening allergic reaction if they consume these products. The recalled retail package items: All Best Before dates Deluxe Dark Chocolate Almonds 20oz. UPC: 034325078741 Deluxe Dark Chocolate Almonds 14oz. UPC:034325747661 Deluxe Dark Chocolate Raisins 24oz. UPC:034325078758 Deluxe Dark Chocolate Raisins 16oz. UPC:034325147669 MedWatch - The FDA Safety Information and Adverse Event Reporting Program [Posted 11/03/2017] AUDIENCE: Pharmacy, Surgery, Risk Manager, Consumer ISSUE: Fresenius Kabi USA is voluntarily recalling Lot of Midazolam Injection, USP, 2 mg/2 mL packaged in a 2 mL prefilled single-use glass syringe to the hospital/user level. The product mislabeled as Midazolam Injection, USP, 2 mg/2 mL contains syringes containing and labeled as Ondansetron Injection, USP, 4 mg/2 mL. BACKGROUND: A missed dose of midazolam may lead to ineffective sedation and/or anxiety related to patient recall of a surgical or diagnostic procedure. If a selection error occurs, a patient who may have received a pre-operative dose of ondansetron may inadvertently receive an additional dose of ondansetron. Dose-dependent serious cardiac arrhythmias may be observed with higher dosages of ondansetron in those patients with certain pre-existing cardiac conditions. Patients may also be at risk for serotonin syndrome. Serotonin syndrome is associated with increased serotonergic activity in the central nervous system. Most reports of serotonin syndrome have been associated with concomitant use of certain drugs, some commonly used during surgery, such as fentanyl. Some of the reported cases of serotonin syndrome were fatal. RECOMMENDATION: Fresenius Kabi is notifying its distributors and customers by letter and is arranging for return of the recalled product. If health care facilities have the affected lot, they are to immediately discontinue distributing, dispensing or using the lot and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that have been shipped, or may have been shipped the product involved in this recall. Consumers with questions regarding this recall can contact Fresenius Kabi Quality Assurance at 1-866-716-2459. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product. 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 Drug Safety Communication, at:https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm583860.htm Ridge Properties DBA Pain Relief Naturally Issues Voluntary Nationwide Recall of all lots of Naturally HL Bedsore Cream, Pretat by TAT Balm Carbomer Free Gel, & All Naturally HL Hemorrhoid products due to manufacturing concerns at the facility Ridge Properties DBA Pain Relief Naturally is voluntarily recalling all lots within expiry of Naturally HL Bedsore Relief Cream, Extra Strength PreTAT by TAT Balm Carbomer Free Gel and Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine manufactured by Ridge Properties dba Pain Relief Naturally, Salem, Oregon to the consumer level. These products are being recalled after an FDA inspection found significant violations of current good manufacturing practice regulations. Manufacturing practices that are not in adequate control represent the possibility of risk being introduced into the manufacturing process in decreased quality and consistency (i.e., the safety, identity, strength, quality and purity). Ridge Properties has received reports of subpotency in Extra Strength PreTAT by TAT Balm Carbomer Free Gel Physio-Control Launches Voluntary Field Action for Specific Production Lots of Infant/Child Reduced Energy Defibrillation Electrodes Produced by Cardinal Health Physio-Control announced today that the company is launching a voluntary field action for specific production lots of Infant/Child Reduced Energy Defibrillation Electrodes (defibrillation electrodes) produced by Cardinal Health. The company is notifying customers of an issue with the artwork on the defibrillation electrodes, as manufactured by Cardinal Health, which shows incorrect electrode placement for an infant. There is no issue with the performance or function of the defibrillation electrodes; this is limited to incorrect artwork on the defibrillation electrodes within the packaging. If the user incorrectly places the defibrillation electrodes, it may result in ineffective energy delivery to the patient and serious injury or death. The defibrillation electrodes are used only with LIFEPAK EXPRESS® AED, LIFEPAK CR® Plus AED, LIFEPAK® 1000 defibrillator, or LIFEPAK 500 Biphasic AED with a pink connector. Adult defibrillation electrodes are not impacted. Approximately 14,200 electrodes have been affected. There have been no customer complaints reported for this issue.  Νοεμ 3 τις 8:47 μ.μ. Parties Agree to Divestiture of Senior Living Facilities Referral Service Caring.com as a Condition of Red Venture’s Acquiring Bankrate Agency Alleges that Proposed Acquisition would likely Harm Competition for Third-Party Paid Referral Services for Senior Living Facilities Red Ventures and Bankrate have agreed to a divestiture of Bankrate’s Caring.com business unit to settle Federal Trade Commission charges that their $1.4 billion merger would likely harm competition in the market for third-party paid referral service for senior living facilities. According to a complaint filed by the FTC, Red Ventures and Bankrate supply proprietary internet content and customer leads for a variety of industries. Caring.com is a wholly-owned subsidiary of Bankrate which competes in the market for third-party paid senior living facilities referral services. Two of Red Ventures’ largest shareholders jointly own A Place for Mom.com; the largest provider of such services, and Caring.com is the second largest provider. According to FTC’s complaint, Caring.com and A Place for Mom.com are each other’s closest competitors, competing for national and local business. Other competitors in the U.S. market for third-party paid referral services for senior living facilities comprise a much smaller fringe. The complaint alleges that the two Red Venture shareholders have the collective ability to significantly influence management of Red Venture and Caring.com. Thus, if consummated, the transaction may increase the chance for Red Ventures to unilaterally exercise market power and the potential for coordinated interaction between Caring.com and A Place for Mom.    Under the terms of the proposed settlement, the parties will divest Caring.com no later than six months after the acquisition and provide transition services to an acquirer. Under the proposed order, the Commission may appoint a monitor to ensure compliance. The parties are also required to establish firewalls related to Caring.com’s confidential business information. Further details about the consent agreement are set forth in the analysis to aid public comment for this matter. The Commission vote to issue the complaint and accept the proposed consent order for public comment was 2-0. The FTC will publish the consent agreement package in the Federal Register shortly. The agreement will be subject to public comment for 30 days, beginning today and continuing through Dec. 5, 2017, after which the Commission will decide whether to make the proposed consent order final. Comments can be filed electronically or in paper form by following the instructions in the “Supplementary Information” section of the Federal Register notice.   NOTE: The Commission issues an administrative 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. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of up to $40,654. The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about how competition benefits consumers or file an antitrust complaint. Like the FTC on Facebook, follow us on Twitter, read our blogs and subscribe to press releases for the latest FTC news and resources.

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