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CDRH New Update

CDRHNew Date: November 9, 2015 The following new items were added to the CDRH web pages on November 6, 2015. Previous CDRH New Items can be found on the CDRHNew Page [ http://www.fda.gov/MedicalDevices/NewsEvents/News/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ]. * November 2015 MedSun Newsletter [ http://www.fda.gov/downloads/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/Newsletters/UCM471737.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery ] * UDI Formats by FDA-Accredited Issuing Agency (November 3, 2015) [ http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/UCM396595.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery ]

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Boulder Natural Meats Recalls Beef, Pork, and Poultry Products Due to Misbranding and Undeclared Allergen

[ http://content.govdelivery.com/accounts/USFSIS/bulletins/123e456?reqfrom=share ] Having trouble viewing this email? View it as a Web page [ http://content.govdelivery.com/accounts/USFSIS/bulletins/123e456 ]. Boulder Natural Meats Recalls Beef, Pork, and Poultry Products Due to Misbranding and Undeclared Allergen [ http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2015/recall-140-2015-release ] Boulder Natural Meats, a Denver, Colo., establishment, is recalling approximately 3,607 pounds of beef, pork, and poultry products due to misbranding and an undeclared allergen.

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Cloverdale Foods Company Recalls Beef and Pork Product Due to Misbranding and Undeclared Allergen

[ http://content.govdelivery.com/accounts/USFSIS/bulletins/123e3fc?reqfrom=share ] Having trouble viewing this email? View it as a Web page [ http://content.govdelivery.com/accounts/USFSIS/bulletins/123e3fc ]. Cloverdale Foods Company Recalls Beef and Pork Product Due to Misbranding and Undeclared Allergen [ http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2015/recall-139-2015-release ] Cloverdale Foods Company, a Mandan, ND, establishment, is recalling approximately 5,208 pounds of beef and pork jalapeño cheddar bratwurst product due to misbranding and an undeclared allergen.

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Blue Buffalo Company, Ltd. Voluntarily Recalls Limited Production of Kitty Yums Chicken Recipe Cat Treats Due to the Presence of Propylene Glycol

*U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition* *Food Safety Alerts*

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Maple Leaf Foods Inc. Recalls Boneless Pork Products Produced Without Benefit of Import Inspection

[ http://content.govdelivery.com/accounts/USFSIS/bulletins/123c9b6?reqfrom=share ] Having trouble viewing this email? View it as a Web page [ http://content.govdelivery.com/accounts/USFSIS/bulletins/123c9b6 ]. Maple Leaf Foods Inc. Recalls Boneless Pork Products Produced Without Benefit of Import Inspection [ http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2015/recall-138-2015-release ] Maple Leaf Food Inc., a Manitoba, Canada establishment, is recalling approximately 4,030 pounds of boneless pork shoulders products that were not presented at the U.S. point of entry for inspection.

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Brett Anthony Foods Issues Allergy Alert on Undeclared Peanut, Egg, Sulfite in Whole Foods Brand Tofu Curry Cous Cous Box 16oz

*U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition* *Food Safety Alerts*

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World Variety Produce, Inc. Voluntarily Recalls Italian Pine Nuts Because of Possible Health Risk

*U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition* *Food Safety Alerts*

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You are subscribed to Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA). This information has recently been updated and is now available.   World Variety Produce, Inc. Voluntarily Recalls Italian Pine Nuts Because of Possible Health Risk [ ] 11/06/2015 02:46 PM EST World Variety Produce, Inc. of Los Angeles, CA is voluntarily recalling Italian Pine Nuts 2oz and 3oz, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever,diarrhea (which may be bloody), nausea, vomiting and abdominal pain. For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

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You are subscribed to Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA). This information has recently been updated and is now available.   Brett Anthony Foods Issues Allergy Alert on Undeclared Peanut, Egg, Sulfite in Whole Foods Brand Tofu Curry Cous Cous Box 16oz [ ] 11/06/2015 02:50 PM EST Brett Anthony Foods of Elk Grove Village Illinois is recalling two 16oz containers of Tofu Curry Cous Cous Box because it may contain undeclared peanut, egg, sulfite. People who have an allergy or severe sensitivity to peanut, egg, sulfite run the risk of serious or life-threatening allergic reaction if they consume these products. For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

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Athens Foods, Inc. Recalls Beef Products Due to Misbranding and Undeclared Allergens

[ http://content.govdelivery.com/accounts/USFSIS/bulletins/123bfe9?reqfrom=share ] Having trouble viewing this email? View it as a Web page [ http://content.govdelivery.com/accounts/USFSIS/bulletins/123bfe9 ]. Athens Foods, Inc. Recalls Beef Products Due to Misbranding and Undeclared Allergens [ http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2015/recall-137-2015-release ] Athens Foods, Inc., a Cleveland, Ohio establishment, is recalling approximately 168 pounds of beef products due to misbranding and undeclared allergens.

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Drug Shortages Update

FDA (U.S. Food and Drug Administration) [ http://www.fda.gov/?source=govdelivery&utm_medium=email&utm_source=govdelivery ] You are subscribed to Drug Shortages for U.S. Food & Drug Administration (FDA). This information has recently been updated. *November 6, 2015* * FDA Drug Shortages [ http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm?source=govdelivery&utm_medium=email&utm_source=govdelivery ] * Atropine Sulfate Injection [ http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Atropine+Sulfate+Injection&source=govdelivery&st=c&tab=tabs-4&utm_medium=email&utm_source=govdelivery ]   (Updated - Currently in Shortage) * Calcium Chloride Injection, USP [ http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Calcium+Chloride+Injection%2C+USP&source=govdelivery&st=c&tab=tabs-4&utm_medium=email&utm_source=govdelivery ]   (Updated - Currently in Shortage) * Dextrose 5% Injection Bags [ http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Dextrose+5per+Injection+Bags&source=govdelivery&st=c&tab=tabs-4&utm_medium=email&utm_source=govdelivery ]   (Updated - Currently in Shortage) * Dextrose Injection USP, 70% [ http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Dextrose+Injection+USP%2C+70per&source=govdelivery&st=c&tab=tabs-4&utm_medium=email&utm_source=govdelivery ]   (Updated - Currently in Shortage) * Epinephrine Injection [ http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Epinephrine+Injection&source=govdelivery&st=c&tab=tabs-4&utm_medium=email&utm_source=govdelivery ]   (Updated - Currently in Shortage) * Imipenem and Cilastatin for Injection, USP [ http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Imipenem+and+Cilastatin+for+Injection%2C+USP&source=govdelivery&st=c&tab=tabs-4&utm_medium=email&utm_source=govdelivery ]   (Updated - Currently in Shortage) * Levetiracetam (Keppra) Injection [ http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Levetiracetam+%28Keppra%29+Injection&source=govdelivery&st=c&tab=tabs-4&utm_medium=email&utm_source=govdelivery ]   (Updated - Currently in Shortage) * Lidocaine Hydrochloride (Xylocaine) Injection [ http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Lidocaine+Hydrochloride+%28Xylocaine%29+Injection&source=govdelivery&st=c&tab=tabs-4&utm_medium=email&utm_source=govdelivery ]   (Updated - Currently in Shortage) * Metoprolol Injection [ http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Metoprolol+Injection&source=govdelivery&st=c&tab=tabs-4&utm_medium=email&utm_source=govdelivery ]   (Updated - Currently in Shortage) * Piperacillin and Tazobactam (Zosyn) Injection [ http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Piperacillin+and+Tazobactam+%28Zosyn%29+Injection&source=govdelivery&st=c&tab=tabs-4&utm_medium=email&utm_source=govdelivery ]   (Updated - Currently in Shortage) * Potassium Chloride Injection [ http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Potassium+Chloride+Injection&source=govdelivery&st=c&tab=tabs-4&utm_medium=email&utm_source=govdelivery ]   (Updated - Currently in Shortage) * Sodium Chloride 0.9% Injection Bags [ http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Sodium+Chloride+0.9per+Injection+Bags&source=govdelivery&st=c&tab=tabs-4&utm_medium=email&utm_source=govdelivery ]   (Updated - Currently in Shortage) * Sodium Chloride 23.4% Injection [ http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Sodium+Chloride+23.4per+Injection&source=govdelivery&st=c&tab=tabs-4&utm_medium=email&utm_source=govdelivery ]   (Updated - Currently in Shortage) * Sufentanil Citrate (Sufenta) Injection [ http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Sufentanil+Citrate+%28Sufenta%29+Injection&source=govdelivery&st=c&tab=tabs-4&utm_medium=email&utm_source=govdelivery ]   (Updated - Currently in Shortage) * Vancomycin Hydrochloride for Injection, USP [ http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Vancomycin+Hydrochloride+for+Injection%2C+USP&source=govdelivery&st=c&tab=tabs-4&utm_medium=email&utm_source=govdelivery ]   (Updated - Currently in Shortage) *Download the Drug Shortages Mobile Application *New! Drug Shortages 2 Mobile App for Android adds alert feature. Download iOS App [ https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewSoftware?id=944986401&mt=8&source=govdelivery&utm_medium=email&utm_source=govdelivery ]   Download Android App Black [ https://play.google.com/store/apps/details?id=gov.fda.drugshortages2&source=govdelivery&utm_medium=email&utm_source=govdelivery ]

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Drug Information Update- New FDA Drug Safety Communication on Plavix (clopidogrel)

FDA Division of Drug Information: Know the Moment It Happens The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

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FDA MedWatch - Plavix (clopidogrel): Drug Safety Communication - Long-term Treatment Does Not Change Risk of Death

MedWatch logoMedWatch - The FDA Safety Information and Adverse Event Reporting Program Plavix (clopidogrel): Drug Safety Communication - Long-term Treatment Does Not Change Risk of Death *AUDIENCE*: Cardiology, Hematology, Surgery *ISSUE*: An FDA review has determined that long-term use of the blood-thinning drug Plavix (clopidogrel) does not increase or decrease overall risk of death in patients with, or at risk for, heart disease. FDA evaluation of the Dual Antiplatelet Therapy (DAPT) trial and several other clinical trials also does not suggest that clopidogrel increases the risk of cancer or death from cancer. In order to investigate the increased risk of death and cancer-related death reported with clopidogrel in the DAPT trial, FDA examined the results of the DAPT trial and other large, long-term clinical trials of clopidogrel with data available on rates of death, death from cancer, or cancer reported as an adverse event. FDA performed meta-analyses of other long-term clinical trials to assess the effects of clopidogrel on death rates from all causes. The results indicate that long-term (12 months or longer) dual antiplatelet therapy with clopidogrel and aspirin do not appear to change the overall risk of death when compared to short-term (6 months or less) clopidogrel and aspirin, or aspirin alone. Also, there was no apparent increase in the risks of cancer-related deaths or cancer-related adverse events with long-term treatment. FDA is working with the manufacturers of clopidogrel to update the label to reflect the results of the mortality meta-analysis. *BACKGROUND*: Clopidogrel is an antiplatelet medicine used to prevent blood clots in patients who have had a heart attack, stroke, or problems with the circulation in the arms and legs. It works by helping to keep the platelets in the blood from sticking together and forming clots that can occur with certain medical conditions. *RECOMMENDATION*: Patients should not stop taking clopidogrel or other antiplatelet medicines because doing so may result in an increased risk of heart attacks and blood clots. Talk with your health care professional if you have any questions or concerns about clopidogrel. Health care professionals should consider the benefits and risks of available antiplatelet medicines before starting treatment.  See the Drug Safety Communication [ http://www.fda.gov/Drugs/DrugSafety/ucm471286.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ] for more information, including Additional Information for Patients, Caregivers, and Health Care Professionals, and a Data Summary. 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 [ http://www.fda.gov/MedWatch/report?source=govdelivery&utm_medium=email&utm_source=govdelivery ] * Download form [ http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ] 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 Drug Safety Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm471531.htm [ http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm471531.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ]

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USDA Names Minority Farmers Advisory Committee

Having trouble viewing this email? View it as a Web page [ http://content.govdelivery.com/accounts/USDAOC/bulletins/123b468 ]. Header Press Release You are subscribed to USDA Office of Communications.   Release No. 0309.15 Contact: Office of Communications (202)720-4623   USDA Names Minority Farmers Advisory Committee   WASHINGTON, November 6, 2015 - Agriculture Secretary Tom Vilsack has appointed members of the USDA Minority Farmers Advisory Committee (MFAC). The committee provides farmer, rancher, industry and public perspectives on USDA strategies, policies and programs that impact minority farmers and ranchers. The Committee held its first public meeting September 22-24, 2015, in Savannah, Ga., to consider a number of related issues including the Department's outreach and assistance for Socially Disadvantaged and Veteran Farmers and Ranchers Grant Program (also known as the 2501 Program). Committee members serve two-year appointments expiring in June 2017. Committee members include: * Alfonzo Abeyta of A Quarter Circle Lazy 5 Ranch, Antonito, CO * Terry A. Cannon of The Piney Woods School, Braxton, MS * Jennie Crittendon of FSA County Office Committee, Jackson, MI * Claud D. Evans of Okfuskee County Veterinary Clinic, Okemah, OK * Paula Garcia (Chair) of New Mexico Acequia Association, Mora, NM * Dewayne L. Goldmon of Monsanto/National Black Growers Council, Pine Bluff, AR * Edward C. DeLeon Guerrero of Saipan Farm and Garden, Saipan, M.P. * William R. Miller, Jr. of Ohio Farmers Union, Oxford, OH * Igalious "Ike" Mills of Texas Small Farmers and Ranchers, Port Arthur, TX * Frederick Newhouse of Newhouse Land and Cattle, Houston, TX * Harvey Reed of Louisiana Association of Cooperatives, Gretna, LA * Renard F. Turner of Virginia State University, Gordonsville, VA * Randall S. Ware (Vice Chair) Indian Country Agriculture and Resource Development Corp., Fort Cobb, OK * Charles Linwood Whitaker of Whitaker Small Farm Group, Raleigh, NC * John Zippert of Federation of Southern Cooperatives, Eutaw, AL MFAC [ http://www.outreach.usda.gov/sdfr/FAC.htm ] is the public advisory arm of the 2501 Program administered by USDA's Office of Advocacy and Outreach [ http://www.outreach.usda.gov/ ] (OAO). Established by the 2008 Farm Bill, OAO works across all USDA agencies to improve the viability and profitability of small and beginning farmers and ranchers; increase access to USDA programs for historically underserved communities; grow agricultural opportunities for farm workers; and close the professional achievement gap by expanding opportunities for diverse, talented young people working in the American agricultural sector. # [ http://content.govdelivery.com/accounts/USDAOC/bulletins/123b468?reqfrom=share ]

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National Center for Toxicological Researh log with FDA on left side You are subscribed to NCTR Research Highlights for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available [ ].

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You are subscribed to Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA). This information has recently been updated and is now available.   Kozy Shack Recalls One Lot of Kozy Shack Indulgent Recipe Pudding [ ] 11/05/2015 08:38 PM EST Kozy Shack Enterprises LLC is recalling one lot of Kozy Shack Indulgent Recipe Pudding in a Salted Caramel cardboard sleeve because it may contain Vanilla Bean Pudding cups, which contain egg. The Salted Caramel cardboard sleeve does not include egg in the ingredient statement. For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

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You are subscribed to Food Allergy Alerts for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available. Kozy Shack Recalls One Lot of Kozy Shack Indulgent Recipe Pudding [ ] 11/05/2015 08:38 PM EST Kozy Shack Enterprises LLC is recalling one lot of Kozy Shack Indulgent Recipe Pudding in a Salted Caramel cardboard sleeve because it may contain Vanilla Bean Pudding cups, which contain egg. The Salted Caramel cardboard sleeve does not include egg in the ingredient statement.