FDA/USDA~May*June ~2019~ Alerts & Safety


  • Life Rising Corporation of Willowbrook, IL is recalling Life Rising Holder-W Holder Warmer capsules, Life Rising NECK-ND Neck Clear capsules, and HoliCare Metabolism Cleansing (MET-CLS) tablets because the products have the potential to contain excessive levels of lead. According to FDA instruction, lead can accumulate in the body over time and too much of it can cause serious and sometimes permanent adverse health consequences. People with high blood levels of lead may show no symptoms, but the condition may cause damage to the nervous system and internal organs. Acute lead poisoning may cause a wide range of symptoms, including abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Children are particularly vulnerable to lead poisoning. Lead poisoning can be diagnosed through clinical testing.
    The recalled products were mostly sold locally in Chicago area at HoliCare clinics and a limited quantity were also distributed through mail orders.
    The recall includes all products purchased before May 2, 2019 of the Life Rising Holder-W Holder Warmer capsules and Life Rising NECK-ND Neck Clear capsules and lot number T81171040 of the HoliCare Metabolism Cleansing (MET-CLS) tablets. The Life Rising Holder-W Holder Warmer capsules are sold in a bottle with 54 capsules, the Life Rising NECK-ND Neck Clear capsules are sold in a bottle with 54 capsules, and the HoliCare Metabolism Cleansing (MET-CLS) tablets are sold in a bottle with 60 tablets, marked with lot # T81171040 on the bottom.
    No illnesses have been reported to date.
    The recall was initiated after it was discovered based on sampling by U.S. Food and Drug Administration that the products contained high levels of lead which exceeded the new daily limit guidelines of 3 µg per day for children, the 12.5 µg per day for adults which we were informed by FDA on May 1, 2019.
    The sale of these products has been suspended and inventory put on hold while FDA and the company continue to investigate the source of the problem. Consumers who have purchased these products should not consume them and are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-630-654-0617 central standard time, Monday to Friday, from 9:00AM to 4:30PM.
  • Out of an abundance of caution, Mecox Bay Dairy, LLC, is recalling their Mecox Sunrise washed-rind Tomme style cheese because it has the potential to be contaminated with Listeria monocytogenes, 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 monocytogenes infection can cause miscarriages and stillbirths among pregnant women.
    This cheese was distributed and sold at seven retail locations and one restaurant on Eastern Long Island, NY, and served at one restaurant in Chicago, IL. The product comes in a clear plastic package marked with “Mecox Sunrise” cheese label. As of the date of this release, all affected Mecox Sunrise has been removed from all stores and restaurants.
    No illnesses have been reported to date in connection with this problem. The potential for contamination was noted after routine testing by New York State Agriculture and Markets Division of Milk Control revealed the presence of Listeria monocytogenes in a sample of Mecox Sunrise cheese.
    The production of the product has been suspended while FDA, New York State Agriculture and Markets, and Mecox Bay Dairy continue to investigate the source of the problem. Consumers who have purchased any “Mecox Sunrise” cheese are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company between 8:00am and 6:00pm EST at 631-537-0335.
  • If your email program has trouble displaying this email, view it as a web page.MedWatch – The FDA Safety Information and Adverse Event Reporting ProgramA MedWatch Safety Alert was just added to the FDA Recalls webpage.TOPIC: Candy King – Worms 3 mg 100 mL by Drip More: Recall – Due to Elevated Nicotine Content

    AUDIENCE: Consumer, Health Professional

    ISSUE: Drip More, LP (Drip More) is voluntarily recalling four lots of Candy King – Worms 3mg/100mL that were produced by a contract manufacturer. The product has been found to contain a higher concentration of nicotine than the label indicates. The higher concentration of nicotine has the potential to cause immediate and potentially serious adverse health effects. Symptoms of nicotine over exposure may include nausea, vomiting, rapid heart rate, pale skin, headache, dizziness, confusion, and seizures. Any accidental nicotine exposure in children may be harmful or fatal. Seek immediate medical attention if needed or call the Poison Control Center at 1-800-222-1222.

    The recall applies to the following product: Candy King – Worms 3mg 100ml. To identify the affected product, consumers should look for the following information:

    • Candy King – Worms 3mg/100ml – Lot Number: WO03021819-1
    • Candy King – Worms 3mg/100ml – Lot Number: WO03021819-2
    • Candy King – Worms 3mg/100ml – Lot Number: WO03021819-3
    • Candy King – Worms 3mg/100ml – Lot Number: WO03021819-4
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  • Deep Foods Inc. of Union, NJ is recalling Deep Golden Raisin 7oz., 14oz. and 28oz. Because they contained undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.The recalled “Deep Golden Raisin” were distributed nationwide in retail stores.The product comes in 7 oz.(Upc code 01143313432) 14 oz.(Upc code 011433133449) and 28 oz.(Upc code 011433433457) Clear plastic bags.No illness have been reported to date in connection with this problem.

    The recall was initiated after routing sampling by Florida Department of Agriculture and Consumer services and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in the 7 oz. Package of Deep “Golden Raisin” which were not declared on label. The same raisins were packed in 14 oz. And 28 oz.

  • purely elizabeth Voluntarily Recalls Granola Due to Potential Presence of Foreign Material We want to inform you that we have initiated a voluntary recall on several of our Grain-Free Granola offerings due to possible foreign matter contamination. If you have purchased our Coconut Cashew Grain-Free Granola, Banana Nut Butter Grain-Free Granola or our Pumpkin Spice + Ashwagandha Grain-Free Superfood Granola, they may be impacted by this recall. We are implementing this recall, because we learned that cashews provided by our supplier during a brief time this spring may contain foreign objects. We have taken corrective action and replaced this cashew supplier with a new one. Please reach out to our team with any questions or concerns via email support@purelyelizabeth.com or call (720)242-7525 Ext. 106, 9AM – 5PM MST, Monday through Friday.Product Photos

    Product Photos

  • Blount Fine Foods, a McKinney, Texas establishment, is recalling approximately 6,690 pounds of soup with chicken products that may be contaminated with extraneous materials, specifically plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The ready-to-eat chicken tortilla soup items were produced on April 26, 2019. The following products are subject to recall: [View Labels (PDF only)]
    16-oz. plastic bowls containing “Panera BREAD at HOME Chicken Tortilla Soup” with a “Use By date” of 07/05/2019 and lot codes 042619-3V or 042619-4V printed on the bottom of the container.
    The products subject to recall bear establishment number “P-13130” inside the USDA mark of inspection. These items were shipped to distribution centers and retail locations in Arizona, Florida, and Georgia. This recall only impacts Panera Bread at Home products. It does not include any product sold at Panera Bread restaurants.There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.Consumers with questions about the recall can contact the Blount Fine Foods Consumer Care Team at (866) 674-4519 or visit http://www.blountfinefoods.com/recall. Members of the media with questions about the recall can contact Larry Marchese, Managing Partner, Legion Thirteen, at (617) 733-8899.
  • BEF Foods, Inc., a Lima, Ohio establishment, is recalling approximately 527 pounds of beef pasta products that were produced without the benefit of federal inspection and outside of inspection hours, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The ready-to-eat beef stroganoff pasta items were produced on May 3, 2019. The following products are subject to recall: [View Label (PDF only)]
    18-oz. sealed plastic trays containing “Bob Evans Beef Stroganoff Pasta” with a USE BY date of 07/02/19 and a time-stamp ranging between the hours of 15:00 and 18:37 represented on the tray seal.
    The products subject to recall bear establishment number “EST. M-46062” inside the USDA mark of inspection. These items were shipped to retail locations in Alabama, Georgia, Illinois, Indiana, Kentucky, Michigan, and Ohio.There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.Consumers and members of the media with questions about the recall can contact BEF Foods, Consumer Relations at (800) 939-2338.
  • Terumo Medical Corporation Recalls SOLOPATH® Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System Due to Dislodgement of the Fairing Tip from the Sheath On April 30, 2019, Terumo sent customers a product discontinuance notification
    External Link Disclaimer
    and a voluntary recall notice to customers
    External Link Disclaimer
    , which listed the following actions:
    Review the Product Recall Bulletin and the Required Actions.
    Assure that all users receive notice of this issue so that required actions can be performed.
    Assure that this notice is forwarded to applicable facilities if any affected products were further distributed outside of your facility.
    Review your SOLOPATH inventory immediately to identify and isolate affected inventory to prevent future use.
    Complete the Medical Device Recall Response Form. The form is required even if you do not have product to return.
    If you have product to return, contact Stericycle to obtain a credit and reference event number 10082. Phone Number: 855-205-2627 E-Mail: return to terumo10082@stericycle.com.
    E-mail the Recall Acknowledgement Form to terumo10082@stericycle.com to arrange for product to be returned to Stericycle.
    Terumo encourages customers to consider alternative suppliers.
    Contact Information
    For questions or concerns regarding this notification, please call Terumo at 1-800-888-3786.
    Full List of Affected Devices
    Product Name
    SOLOPATH® Balloon Expandable TransFemoral System
    SOLOPATH® Re-Collapsible Balloon Access System
    Product Models
    STFI-1425
    STFI-1435
    STFI-1625
    STFI-1635
    STFI-1825
    STFI-1835
    STFI-1925
    STFI-1935
    STFI-2125
    STFI-2135
    SR-1925
    SR-1935
    SR-2025
    SR-2035
    SR-2225
    SR-2235
    SR-2425
    SR-2435
    Lot Numbers
    All lots within expiry
    All lots within expiry
  • Novis PR LLC está llevando a cabo un recogido voluntario a nivel de consumidor de 5 lotes de PECGEN DMX, 16 oz, jarabe para la tos. La etiqueta del producto contiene un error tipográfico proveyendo dosificación incorrecta.La etiqueta indica dosificación en niños de 2-6 años de edad, una cucharadita cada 4 horas, sin exceder 4 cucharaditas en 24 horas o según indique su médico. La dosificación correcta debe indicar niños de 6-12 años de edad, una cucharadita cada 4 horas, sin exceder 4 cucharaditas en 24 horas o según indique su médico. En adición, la etiqueta no provee recomendación a los consumidores de consultar a su médico sobre uso para niños menores de 2 años de edad.Riesgos: No hay evidencia que los jarabes para el catarro sean seguros o efectivos para niños pequeños. Hay evidencia que podrían llegar a causar sobre dosis en niños pequeños. Problemas pudieran presentar convulsiones, coma y/o muerte. Dextrometorfano puede interactuar con Tylenol y otros jarabes pudiendo tener una reacción toxica. Hasta la fecha, Novis PR LLC no ha recibido ninguna queja o evento adverso relacionado a este recogido.
  • Novis PR LLC is voluntarily recalling 5 lots of PECGEN DMX, 16 oz, a liquid cough syrup to the consumer level. The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label (example below) incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.The product is used as a Cough suppressant and expectorant and is packaged in Amber plastic 16 oz bottles in cases of 12 units with NDC 52083-630-16. The affected PECGEN DMX lots include the following lot numbers and expiration dates: D80202 Exp date 02/20, D80210 Exp 02/20, D80818 Exp 09/20, D80819 Exp 09/20, D80820 Exp 09/20.
    Error was discovered by an email notification of an unidentified individual alerting of incorrect information in label.
    PECGEN DMX was distributed in Puerto Rico to Wholesalers and retail pharmacies. Product is only sold in Puerto Rico.
    Novis PR LLC is notifying its distributors and customers by letters and phone calls the collection of the units and is arranging the return of all recalled products.
    Consumers who have PECGEN DMX which is being recalled should stop using/return to place of purchase/discard/contact their doctor, etc.
    Distributors/retailers that have PECGEN DMX which is being recalled should stop distributing the product and must return it to place of purchase. To date, NOVIS PR LLC has not received any reports of adverse events related to this recall.
    Consumers with questions regarding this recall can contact Novis PR LLC at (787) 767-2072 or info@kramernovis.com from Monday thru Friday, 7:30am – 4:30pm (AST).
    Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
    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.
    Complete and submit the report Online: http://www.fda.gov/medwatch/report.htm
    Regular Mail or Fax: Download form http://www.fda.gov/MedWatch/getforms.htm 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
    This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
  • Johnsonville, LLC., a Sheboygan Falls, Wis. establishment, is recalling approximately 95,393 pounds of its ready-to-eat jalapeño cheddar smoked sausage products that may be contaminated with extraneous material, specifically hard green plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The jalapeño cheddar smoked sausage items were produced and packaged on March 12 and 13, 2019. The following products are subject to recall: [View labels (PDF only)]
    14-oz. film, vacuum packages containing “Johnsonville JALAPEÑO CHEDDAR Smoked Sausage” with a “Best By 06/09/2019” date on the back of the package.
    The products subject to recall bear establishment number “EST. 34224” inside the USDA mark of inspection. These items were shipped nationwide and internationally.There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
    Consumers with questions about the recall can contact Kirsten Bishir, Johnsonville, LLC. Consumer Relations Coordinator, at KBishir@johnsonville.com and by phone or text at 1-888-556-2728. Members of the media with questions about the recall can contact Stephanie Dlugopolski, Johnsonville, LLC. Public Relations and Social Media Manager, at SDlugopolski@johnsonville.com.
  • Los Hernandez, LLC., a Moxee, Wash. establishment, is recalling approximately 9,090 pounds of chicken and pork tamales that were produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The tamale products were produced from Dec. 3, 2018 through Feb. 7, 2019. The following products are subject to recall: [View labels (PDF only)]
    30-lb. boxes of “Los Hernandez Authentic Pork TAMALES Hand Made”.
    30-lb. boxes of “Los Hernandez Authentic Chicken TAMALES Hand Made”.
    These items were shipped to a Los Hernandez Tamales Restaurant in Union Gap, Washington, owned by the recalling establishment. The individual tamales may have been packaged and sold to consumers from December 2018 through May 1, 2019. There are no specific identifying labels for consumers who may have carried out the tamales from the restaurant.There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.Consumers and members of the media with questions about the recall can contact Felipe Hernandez, President, Los Hernandez Tamales, LLC, at (509) 571-1394.
  • Perdue Foods LLC., a Bridgewater, Va. establishment, is recalling approximately 31,703 pounds of ready-to-eat chicken products that may be contaminated with extraneous materials, specifically pieces of bone material, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The fully cooked chicken products were produced on March 21, 2019. The following products are subject to recall: [View labels (PDF only)]
    11.2 oz. plastic trays containing “PERDUE Simply Smart ORGANICS BREADED CHICKEN BREAST TENDERS – GLUTEN FREE” with a “USE BY MAY 20 2019” and UPC bar code of 072745-001437 on the label.
    12 oz. plastic trays containing “PERDUE Simply Smart ORGANICS BREADED CHICKEN BREAST NUGGETS – WHOLE GRAIN” with a “USE BY MAY 20 2019” and UPC bar code of 072745-001642 on the label.
    12 oz. plastic trays containing “PERDUE Simply Smart ORGANICS BREADED CHICKEN BREAST STRIPS – WHOLE GRAIN” with a “USE BY MAY 20 2019” and UPC bar code of 072745-002656 on the label.
    10-lb. bulk boxes of “Chef Quik Breaded Chicken Tenders Boneless Tender Shaped Chicken Breast Patties with Rib Meat” with Case Code 22143 on the label.
    10-lb. bulk boxes of “Chef Quik Chicken Breast Strips Strip Shaped Breaded Chicken Breast Patties with Rib Meat” with Case Code 77265 on the label.
    The products subject to recall bear establishment number “EST. P-369” inside the USDA mark of inspection. These items were shipped to retail locations nationwide.
    The problem was discovered after FSIS and the company received consumer complaints.
    There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.Media with questions about the recall can contact Bill See, Senior Manager of Corporate Communications, Perdue Foods, LLC., at (410) 341-2533. Consumers should call the Perdue Consumer Care line at (866) 866-3703.
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