Category Archives: ~ FDA/USDA ~~ Alerts & Safety

a list of recent recalls as published by the FDA /USDA~ Recalls, Market Withdrawals and Safety Alerts

USA.gov … Beware of Skin Lotions Tainted with Mercury


a repost for those buying  gifts …

Beware of Skin Lotions Tainted With Mercury

Some skin lotions and antiseptic soaps claim to clean and lighten skin while removing freckles and wrinkles. Instead, these illegally imported cosmetic products make consumers ill from exposure to high levels of mercury.

The U.S. Government is warning consumers about these products after dozens of people in at least seven states were diagnosed with mercury poisoning. Victims include a woman in California who was hospitalized after using an unlabeled skin lotion for three years. Several members of her family also had high levels of mercury in their bodies, even though they didn’t use the lotion.

“Exposure to mercury can damage your kidneys and nervous system. It also interferes with brain development in unborn babies and very young children,” said Gloria Sánchez-Contreras, a spokesperson for the Food and Drug Administration.

See the names and photos of some of the illegal products.

Immigrants Are at High Risk

The FDA has identified dozens of products that contain high levels of mercury, and has taken steps to deny shipments of these products into the United States. However, many of these lotions and soaps are brought into the country by mail or by international travelers. Once here, they often end up on store shelves that cater to immigrants, including Hispanics, Asians, Africans and people from the Middle East.

People who buy these products are not putting only their own health at risk, small children can also be exposed to mercury by breathing in the vapors of a skin lotion or by touching someone who has used the cream and then putting their fingers in their mouth. “That’s why it’s so important for consumers and sellers to know about the dangers of possible mercury poisoning associated with the use of or exposure to these skin products,” said Sánchez-Contreras.

“That’s why it’s so important for consumers and sellers to know about the dangers of possible mercury poisoning associated with the use of or exposure to these skin products,” said Sánchez-Contreras.

How to Avoid These Products

The FDA prohibits the use of mercury in skin lotions and cosmetic soaps manufactured abroad. To avoid skin lightening and anti-aging products tainted with mercury, stay away from products that:

  • Do not clearly list ingredients on the label.
  • Include the words “mercurous chloride,” “calomel,” “mercuric,” “mercurio,” or “mercury” in their labels.
  • Have labels written in other languages unless they also include a clear description in English.

What to Do If Exposed to Mercury

Be alert for signs of mercury poisoning, which include irritability, changes in vision and hearing, memory loss, depression and numbness in the hands, feet or mouth. If you suspect you have been using products tainted with mercury, stop using them immediately and do the following:

  • Wash your hands thoroughly as well as any other part of the body that might have come into contact with the product.
  • Contact your doctor or health clinic.
  • If you have questions call the National Capital Poison Center at 1 (800) 222-1222.

You can also report the adverse effects of any drug or product on the FDA.gov website or by calling (800) 332-1088.

See the names and photos of some of the illegal products.

first posted 4/11/2012

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FDA/USDA ~~ Jan 2018 Alerts & Safety pg4


 

  • Kareway Products, Inc is voluntarily recalling 60,000 lots of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial contamination which compromises sterility.Risk Statement: The product potentially could be calamitous for any population due to a probability of a potentially sight threatening eye infection or impairment. Kareway Products, Inc has not received any reports of adverse events related to this recall.The product is used as eye wash to clean, refresh, soothe eyes for daily use or emergency eye cleansing by flushing foreign material. It is packaged in 4 fluid ounce (118 ml) bottles. The affected Gericare Eye Wash, Sterile Eye Irrigation Solution lots include the following Lot#86041601 and expiration date of 09/2019. The product can be identified by UPC 3-57896-18604-3. The product was distributed Nationwide to wholesale businesses.Kareway Products, Inc is notifying its distributors and customers by recall letter and is arranging for return or disposal of all recalled products. Consumers and businesses that have product which is being recalled should stop using and selling them immediately.

    Consumers with questions regarding this recall can contact the Recall Department at 310-532-0009 or recall@kareway.com available Monday through Fridays from 08:30 am to 05:30 pm (Pacific Time). 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.

    This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

  • Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA’s request. FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel.Between January 1, 2007, and November 9, 2017, FDA received 30 adverse event reports of elevated liver function tests or acute hypersensitivity pneumonitis associated with the use of Limbrel products. These conditions present in rare cases with varying degrees of severity in patients taking Limbrel for the first time in the initial weeks of exposure, and may go unnoticed by the patient until they consult with their physician or until symptoms develop that require hospitalization. There have been no deaths reported with the use of Limbrel, and in all reported cases adverse effects resolved without residual effects after discontinuing use of the product.Primus retained independent medical and former senior FDA safety experts to conduct a further investigation of these cases and the ingredients in Limbrel.  It is the opinion of these experts based on a thorough review of the medical literature, adverse event reports to FDA, and FDA’s health hazard evaluation that there is no basis on which to conclude that Limbrel potentially causes life-threatening adverse effects, and that none of the reported adverse events show liver failure or respiratory failure. Nonetheless, in an effort to cooperate with FDA, Primus voluntarily ceased its promotion and distribution of Limbrel on December 21, 2017, and is now recalling Limbrel as FDA has requested.All lots within expiry of the following products are included in this recall:
    • Limbrel (flavocoxid) 250 mg capsules, Product Identity Number 68040-601-16
    • Limbrel250 (250 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules, Product Identity Number 68040-605-16
    • Limbrel (flavocoxid) 500 mg capsules, Product Identity Number 68040-602-16
    • Limbrel500 (500 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules, Product Identity Number 68040-606-16

    Limbrel has been marketed since 2004 as a medical food available only by prescription for patients under active and ongoing supervision of a physician for the dietary management of osteoarthritis (OA), a degenerative disease of the joints and the most common form of arthritis. Prior to marketing, Primus conducted clinical studies that support the efficacy and safety of Limbrel and compiled an extensive dossier providing an analysis of published data to support the medical food status of Limbrel and to establish how the product meets the distinctive nutritional requirements of OA.  Primus stands by the legal status of Limbrel as a medical food. Limbrel products have been distributed nationwide in the USA to wholesalers, pharmacies, and physicians as medical foods without challenge from FDA for over 13 years, with approximately 2 million prescriptions and physician samples dispensed to an estimated 450,000 patients.

    Primus is notifying its distributors by emailed letter and is arranging for the return of all recalled products. Retail pharmacies that have Limbrel products should return them to the wholesale distributor.  FDA has recommended that patients who have the Limbrel products that are being recalled should stop use.

    Patients who wish to return unopened bottles or who have questions regarding this recall should go to Limbrel.com or contact Primus by calling (480-483-1410) on Monday through Friday, 9 AM to 5 PM Mountain Time. Patients should contact their physician or healthcare provider if they have experienced any adverse event that may be related to taking Limbrel.

    Physicians with extensive experience with Limbrel have provided written testimony to FDA confirming the benefits and safety of Limbrel for managing OA and to establish the medical necessity of Limbrel for elderly patients with comorbidities who cannot use NSAIDs and have a strong desire to avoid opioid use if possible.  For these and other patients and their medical professionals who have stated their desire for continued access to Limbrel, Primus will seek to work with FDA to return Limbrel to the market as quickly as possible.  For updates about access to Limbrel go to Limbrel.com.

    Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

  • PANERA BREAD PREEMPTIVELY RECALLS ALL 2 OZ. and 8 OZ. CREAM CHEESE PRODUCTS

    ST. LOUIS, January 28, 2018 – While there have been no reported illnesses, out of an abundance of caution, Panera Bread is conducting a nationwide preemptive, voluntary recall of all 2 oz. and 8 oz. cream cheese products sold in its U.S. bakery-cafes.  This recall was initiated after samples of one variety of 2 oz. cream cheese from a single production day showed a positive result for the presence of Listeria monocytogenes. Tests on cream cheese samples manufactured both before and after the production run in question have all come back negative.

    Despite the finding in only one day of production, Panera Bread is issuing a voluntary recall of all varieties of the 2 oz. and 8 oz. cream cheese.  The products included in the recall are all varieties (see below) of unexpired 2 oz. and 8 oz. cream cheese products with an expiration date on or before 4/2/18. This recall only affects cream cheese sold in Panera Bread United States bakery cafes and does not affect Panera Bread Canadian bakery cafes or any other Panera Bread food products.

    “The safety of our guests and associates is paramount, therefore we are recalling all cream cheese products sold in the US with an active shelf life.  We have likewise ceased all manufacturing in the associated cream cheese facility,” said Blaine Hurst, Panera’s President and CEO.  “Only one variety of 2-oz cream cheese from a single day yielded the positive result. Our intent is to go above and beyond for our guests. You should expect nothing less from Panera.”

    According to the FDA, 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.

    Affected 2 oz. Cream Cheese Varieties (example pictured below):  Plain Cream Cheese, Reduced-Fat Plain Cream Cheese, Reduced-Fat Chive & Onion Cream Cheese, Reduced-Fat Honey Walnut Cream Cheese, Reduced-Fat Wild Blueberry Cream Cheese.

    Affected 8 oz. Cream Cheese Varieties (example pictured below): Plain Cream Cheese, Reduced-Fat Plain Cream Cheese, Reduced-Fat Chive & Onion Cream Cheese, Reduced-Fat Honey Walnut Cream Cheese, Reduced-Fat Wild Blueberry Cream Cheese.

    Consumers in possession of these products should discard them immediately and contact Panera Bread Customer Service at 1-855-6-PANERA from Monday through Sunday, 5:00 AM to 10:00 PM. CST, or visit Panera.custhelp.com for a full refund.

  • Orange Cream Bars and Chocolate Coated Vanilla Ice Cream Bars (January 9, 2018)

    Fieldbrook Foods Corporation recalls orange cream bars, chocolate coated vanilla ice cream bars, and variety packs that included these ice cream bars because they could be contaminated with Listeria monocytogenes. The ice cream bars were sold under a variety of brand names and sold at stores such as Fred Meyer, Dollar Tree, and Kroger.

    Ice Cream Bars recall press release and product photos.


    Hempler’s Family Classic Pepperoni (January 4, 2018)

    Hempler Foods Group, LLC, recalls Hempler’s brand “Family Classic Pepperoni” because it may be contaminated with metal.

    Hempler’s Family Classic Pepperoni recall news release and product labels.


    Shredded Coconut (January 3, 2018)

    Evershing International Trading Company recalls Coconut Tree Brand frozen “Shredded Coconut – Dùa Bào” because it could be contaminated with Salmonella. This product is linked to an outbreak of Salmonella infections.

    Shredded Coconut recall press release and product photo.

    Multistate Outbreak of Salmonella Infections Linked to Shredded Coconut, CDC

  •  Updated information is now available. A list of retail consignees has been posted for recall 006-2018,  Rich Products Corporation Recalls Beef Products due to Possible Listeria Contamination (Jan 24, 2018).
  • National Frozen Foods Corporation (NFFC) is voluntarily recalling a limited quantity of Not-Ready-To Eat Individually Quick Frozen (IQF) green beans and IQF mixed vegetables because they have 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 infection can cause miscarriages and stillbirths among pregnant women.Following cooking preparation instructions on the labels of master cases or packages will effectively reduce the risk of exposure to this bacteriumThis press release includes recalled products distributed to foodservice accounts in bulk and packaged containers in AK, AR, AZ, CA, CO, FL, ID, IL, KS, MI, MS, MT, ND, NE, NM, NV, OR, TN, TX, VA, and WA. The products being recalled listed below were distributed between August 18, 2017 and January 12, 2018.The recalled items can be identified by the date codes printed on the back of the 32oz. sized bag or the side of the master case. Only the following codes are affected by this recall:* The 32 oz. inner clear poly bag has only lot code printed.The recall was initiated based on a 3rd party test result of the IQF Green Beans only by a downstream customer that revealed that the finished products may potentially be contaminated with the bacteria. There has been no report of human illness to date.The frozen green beans and frozen mixed vegetables are being recalled as a precaution with the health and safety of consumers as top priority and in full cooperation with the FDA. The recall has not yet been classified by the FDA.Consumers should not consume these products. Consumers who purchased affected products may return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-253-8269, Monday – Friday 7:30 a.m. to 4 p.m. (Pacific Time).
  • Rich Products Corporation Recalls Beef Products due to Possible Listeria Contamination
    Rich Products Corporation, a Vineland, N.J. establishment, is recalling approximately 3,420 pounds of beef meatball products that may be adulterated with Listeria monocytogenes.
  • FSIS Issues Public Health Alert for Chicken and Pork Products Produced without the Benefit of Inspection
    The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) is issuing a public health alert because Pigeon Caterers, Inc., doing business as Carnival Brands, a New Orleans, La. establishment, produced and distributed approximately 140 pounds of a chicken and pork product without the benefit of federal inspection.
  • JustFoodForDogs (JFFD) of Los Alamitos, CA, is voluntarily recalling its Beef & Russet Potato, Fish & Sweet Potato and Turducken dog food meals in all sizes. JFFD uses 100% USDA and other restaurant grade ingredients in all of its pet food, and because the green beans used in these meals may be contaminated with Listeria monocytogenes, the companyis alerting the public. Listeria monocytogenescan affect animals eating the product and there is risk to humans if they were to intentionally or unintentionally ingest the dog food or come into contact with contaminated feces from a pet that has eaten the food.Listeriosis is rare in dogs and when infected most dogs have mild symptoms such as diarrhea and vomiting, however, more serious symptoms are possible, such as fever, muscular and respiratory signs, abortion and even death. In addition to the possibility of becoming sick, such infected animals can shed Listeria monocytogenes through their feces and thus serve as a source of infection to humans, especially if they have not thoroughly washed their hands. If your dog has consumed the recalled products and has these symptoms, please contact your veterinarian.Healthy people infected with Listeria monocytogenes should monitor themselves for some or all of the following symptoms if they believe they may have consumed any of the above recalled items intentionally or unintentionally, or may have come into contact with contaminated feces from a pet that has eaten the food: nausea, vomiting, diarrhea, aches and fever. Rarely Listeria monocytogenes can result in more serious ailments including arterial infections, endocarditis and can be life threatening. Pregnant women are more susceptible to Listeria infection, which can result in abortion. The most common way that people are affected is by consumption of contaminated food. Consumers exhibiting these signs after consuming this product should contact their healthcare provider.The recalled JFFD Beef & Russet Potato, Fish & Sweet Potato and Turducken was distributed only through 11 JFFD retail locations in Southern California, 3 Pet Food Express (PFE) locations in Southern California and 10 Northern California PFE locations.While testing demonstrates that only several dates of production were affected, out of an abundance of caution, JFFD is recalling all of the above mentioned products made from the dates of November 1, 2017 through January 14, 2018. These represent Best By lot code dates on all three of the JustFoodForDogs’ recalled products of 11/01/18 through 01/14/19.The products being recalled were sold refrigerated or frozen and include all sizes offered – 7 oz, 14 oz, 18 oz and 72 oz.No confirmed Listeriosis has been reported but there have been reports of short-term symptoms in some dogs (diarrhea and vomiting).There have been no reports of human illness to date.The potential for contamination was discovered after a purchaser of JFFD products reported to JFFD veterinary medical staff that her dogs had become ill. Tests to date confirm that green beans purchased from a restaurant supply distributor were positive for Listeria monocytogenes.The restaurant supplier/distributor of these green beans has voluntarily put a “product hold” on the distribution of these green beans to restaurants and other human food retailers.JFFD is currently making these recipes available without green beans until the matter is resolved.JFFD notified and is working with FDA on this matter.Consumers who have purchased the recalled JFFD products from a JFFD store should contact JFFD at 866-726-9509, from 9:00 AM – 7:00PM PST seven days a week, for a full credit or refund. Consumers who have purchased the recalled products from Pet Food Express should return them to any Pet Food Express for a full credit or refund.
  • Arthri-D, LLC is recalling its Dietary Supplement “Arthri-D 120ct” Lot#1701-092 (the “Product”) because it may 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. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.The Product was distributed nationwide through mail orders. It comes in a 225 cc, white plastic HDPE bottle marked with lot #1701-092 on the label and with a manufacturing date of March 2017 stamped on the side.No illnesses have been reported to date in connection with the Product.The potential for contamination was noted after routine testing by the company revealed the presence of Salmonella in 1 bottle. We have tested and re-tested the Product and no presence of Salmonella was subsequently found. However, out of abundance of caution, we have decided to recall this Product.Distribution of the Product has been suspended while FDA and the company continue their investigation as to the source of the Salmonella presentin that aforementioned 1 bottle.Consumers who have purchased 120 count of Arthri-D lot#1701-092 are urged to return them to the place of purchase for a full refund. Consumers with additional questions may contact the company at 978-992-0505.

JustFoodForDogs (JFFD) of Los Alamitos, CA, is voluntarily recalling its Beef & Russet Potato, Fish & Sweet Potato and Turducken dog food meals in all sizes. JFFD uses 100% USDA and other restaurant grade ingredients in all of its pet food, and because the green beans used in these meals may be contaminated with Listeria monocytogenes, the companyis alerting the public. Listeria monocytogenescan affect animals eating the product and there is risk to humans if they were to intentionally or unintentionally ingest the dog food or come into contact with contaminated feces from a pet that has eaten the food.

Listeriosis is rare in dogs and when infected most dogs have mild symptoms such as diarrhea and vomiting, however, more serious symptoms are possible, such as fever, muscular and respiratory signs, abortion and even death. In addition to the possibility of becoming sick, such infected animals can shed Listeria monocytogenes through their feces and thus serve as a source of infection to humans, especially if they have not thoroughly washed their hands. If your dog has consumed the recalled products and has these symptoms, please contact your veterinarian.

Healthy people infected with Listeria monocytogenes should monitor themselves for some or all of the following symptoms if they believe they may have consumed any of the above recalled items intentionally or unintentionally, or may have come into contact with contaminated feces from a pet that has eaten the food: nausea, vomiting, diarrhea, aches and fever. Rarely Listeria monocytogenes can result in more serious ailments including arterial infections, endocarditis and can be life threatening. Pregnant women are more susceptible to Listeria infection, which can result in abortion. The most common way that people are affected is by consumption of contaminated food. Consumers exhibiting these signs after consuming this product should contact their healthcare provider.

The recalled JFFD Beef & Russet Potato, Fish & Sweet Potato and Turducken was distributed only through 11 JFFD retail locations in Southern California, 3 Pet Food Express (PFE) locations in Southern California and 10 Northern California PFE locations.

While testing demonstrates that only several dates of production were affected, out of an abundance of caution, JFFD is recalling all of the above mentioned products made from the dates of November 1, 2017 through January 14, 2018. These represent Best By lot code dates on all three of the JustFoodForDogs’ recalled products of 11/01/18 through 01/14/19.

The products being recalled were sold refrigerated or frozen and include all sizes offered – 7 oz, 14 oz, 18 oz and 72 oz.

No confirmed Listeriosis has been reported but there have been reports of short-term symptoms in some dogs (diarrhea and vomiting).

There have been no reports of human illness to date.

The potential for contamination was discovered after a purchaser of JFFD products reported to JFFD veterinary medical staff that her dogs had become ill. Tests to date confirm that green beans purchased from a restaurant supply distributor were positive for Listeria monocytogenes.

The restaurant supplier/distributor of these green beans has voluntarily put a “product hold” on the distribution of these green beans to restaurants and other human food retailers.

JFFD is currently making these recipes available without green beans until the matter is resolved.

JFFD notified and is working with FDA on this matter.

Consumers who have purchased the recalled JFFD products from a JFFD store should contact JFFD at 866-726-9509, from 9:00 AM – 7:00PM PST seven days a week, for a full credit or refund. Consumers who have purchased the recalled products from Pet Food Express should return them to any Pet Food Express for a full credit or refund.

FDA/USDA ~Jan 2018 Alerts & Safety pg2


  • Rico Brand of Salt Lake City, Utah is recalling Tofu Breakfast Burrito, because it may contain undeclared Soy. People who have an allergy or severe sensitivity to Soy run the risk of serious or life-threatening allergic reaction if they consume these products.Product was distributed in the state of Utah.  The distribution of the Tofu Breakfast Burrito is specifically in these counties, Cache County, Weber County, Salt Lake County, and Utah County  where the product was distributed to grocery stores.

    The Tofu Breakfast Burrito is a twelve ounce burrito wrapped in white paper.  The label contains green, yellow around the border, and orange as the labels center color. Rico Brand logo printed on the top portion of the label. The Julien date is located on the back of the burrito with these two dates: 2687 and 0028.

    No illnesses have been reported to date.

    The recall was initiated after it was discovered that the product “Tofu Breakfast Burrito” containing Soybean was distributed in packaging that did not reveal the presence of Soybean. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s packaging processes.

    Consumers who have purchased Rico Brand’s Tofu Breakfast Burrito are urged to return it to the place of purchase for a full refund. Consumers with questions may contact Rico Brand at 1-801-433-0615 MST Monday to Friday or E-mail Rico Brand at info@ricobrand.com.

     

  • Hom/Ade Foods, Inc is voluntarily recalling Mary B’s® brand biscuits due to potential contamination with Listeria monocytogenes. The problem was discovered in a product sampling conducted by an outside co-packer, who manufactured the product. 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.The Mary B’s products affected are frozen bagged biscuits with the UPC codes listed below. All “Best If Used By” dates BEFORE September 23, 2018 and with the letter “M” immediately after the date are included in the recall. The code may be found on the back of the bag, lower right corner. No other code dates are affected.Products were distributed to AL, AR, CA, FL, GA, IL, IN, KS, KY, LA, MD, MO, MS, NC, OK, OR, PA, SC, TN, TX, VA, WI, WV and sold in retail stores. Although these products are not ready-to-eat items and have baking instructions which, if followed, will reduce consumer risk, there remains some risk that the mishandling of this product prior to or without adequate baking may cause illness.There has been no illness to date associated with these products. Hom/Ade Foods Inc. has voluntarily recalled all affected products and is working with the FDA and supplier to fix the problem. Consumers are urged to return affected products to the place of purchase for a full refund. Customers or consumers with questions may call Hom/Ade Foods Inc. at 1-855-562-7773, Monday to Friday, between 8 a.m. and 5 p.m. Central Time.
  • Fieldbrook Foods Corporation is clarifying that the previously announced voluntary recall of all orange cream bars and chocolate coated vanilla ice cream bars that were produced in 2017 on the company’s Hoyer 1 Line at its Dunkirk, NY plant (plant code 362677) also includes 28,751 cases of Raspberry Cream Bars that were included with Orange Cream Bars in ALDI seasonal split-case purchases. The split-cases were shipped between March and August 2017. These products are being recalled due to the possibility that they may 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 shortterm symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.The Hoyer 1 Line in Dunkirk, NY is the only production line and the only Fieldbrook Foods plant (of 3) involved in this recall notice.The recalled orange cream bars, raspberry cream bars, and chocolate coated vanilla ice cream bars were sold at the following merchants under the indicated brands:
  • Hom/Ade Foods, Inc is voluntarily recalling Mary B’s® brand biscuits due to potential contamination with Listeria monocytogenes. The problem was discovered in a product sampling conducted by an outside co-packer, who manufactured the product. 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.The Mary B’s products affected are frozen bagged biscuits with the UPC codes listed below. All “Best If Used By” dates BEFORE September 23, 2018 and with the letter “M” immediately after the date are included in the recall. The code may be found on the back of the bag, lower right corner. No other code dates are affected.Products were distributed to AL, AR, CA, FL, GA, IL, IN, KS, KY, LA, MD, MO, MS, NC, OK, OR, PA, SC, TN, TX, VA, WI, WV and sold in retail stores. Although these products are not ready-to-eat items and have baking instructions which, if followed, will reduce consumer risk, there remains some risk that the mishandling of this product prior to or without adequate baking may cause illness.There has been no illness to date associated with these products. Hom/Ade Foods Inc. has voluntarily recalled all affected products and is working with the FDA and supplier to fix the problem. Consumers are urged to return affected products to the place of purchase for a full refund. Customers or consumers with questions may call Hom/Ade Foods Inc. at 1-855-562-7773, Monday to Friday, between 8 a.m. and 5 p.m. Central Time.
  • update Fieldbrook Foods Corporation has issued a voluntary recall of all orange cream bars and chocolate coated vanilla ice cream bars that were produced in 2017 on the company’s Hoyer 1 Line at its Dunkirk, NY plant (plant code 362677). This is the only production line and the only Fieldbrook Foods plant (of 3) involved in this recall notice. Both products are being recalled due to the possibility that they may 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 infection can cause miscarriages and stillbirths among pregnant women.The recalled orange cream bars, chocolate coated vanilla ice cream bars, and variety packs that include chocolate coated vanilla ice cream bars were sold at the following merchants under the indicated brands:
  •  Updated information is now available. A list of retail consignees has been posted for recall 001-2018, Hempler Foods Group, LLC Recalls Pepperoni Products due to Possible Extraneous Material Contamination (Jan 4, 2018).
  • Fieldbrook Foods Corporation of Dunkirk NY has issued a voluntary recall of 20 cases of the Tops brand of Orange Cream Bars and 320 cases of the Meijer Purple Cow brand Orange Cream Bars due to the possibility that the product may 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 infection can cause miscarriages and stillbirths among pregnant women. Consumers who have purchased Tops Orange Cream Bars or Meijer Purple Cow Orange Cream Bars are urged to return them to the place of purchase for a full refund.Consumers with questions may contact the company at 1 800/333-0805 x2270. The recalled Top’s Orange Cream Bars were sold in Tops retail stores located in New York, Pennsylvania, Massachusetts, and Vermont.  The product comes in a 12 ct retail box (pictures attached).  The product has a production date of December 18, 2017 and a “best by” date of December 18, 2018.
  • 129-2017, Piller’s Fine Foods Recalls Ready-To-Eat Salami and Speck Products due to Possible Salmonella Adulteration (Dec 16, 2017)
  • Crescent City Meats  Recalls Ready-To-Eat Tasso Ham Products due to UnderprocessingCrescent City Meats, a Metairie, La., establishment, is recalling approximately 430 pounds of Ready-to-Eat (RTE) Tasso Cajun Spicy Ham products because the RTE product may be underprocessed.
  • Reports of E. coli Outbreak Investigations from 2017| E.coli | CDC

    Ecoli Outbreak Investigations from 2017

  • Hempler Foods Group, LLC Recalls Pepperoni Products due to Possible Extraneous Material Contamination Hempler Foods Group, LLC, a Ferndale, Wash. establishment, is recalling approximately 4,068 pounds of pepperoni sticks products that may be contaminated with extraneous material, specifically metal.

 

FDA/USDA ~January Alerts & Safety


 

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 monocytogenesListeria 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

Although these products are not ready-to-eat items and have baking instructions which, if followed, will reduce consumer risk, there remains some risk that the mishandling of this product prior to or without adequate baking may cause illness.

We are working in coordination with the Food and Drug Administration (FDA) and our supplier on this recall.

All affected distributors and retail customers are being notified and the affected products are being removed from store shelves.

Affected product should be destroyed or may be returned to the place of purchase for a full refund. Consumers with questions may contact 1-866-837-2758 between 8 a.m. and 5 p.m. Eastern Time.

  • Updated information is now available. The list of retail consignees has been posted for recalls: 123-2017, Trafon Group Recalls Chicken and Pork Products Produced Without Benefit of Import Inspection (Nov 16, 2017)
  • Evershing International Trading Company is recalling 16 ounces Coconut Tree Brand Frozen Shredded Coconut because they have 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 system. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting in to the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. No illnesses have been reported to date.This coconut products were distributed in Ohio, Massachusetts, Washington, California, Oklahoma, Illinois, Michigan, New Jersey and New York. This Frozen Shredded Coconut product is package in 16 ounces plastic bags. This recall is limited to Lot SE07A1, but the lot number is only printed on the case. Therefore, any customer that purchased this product from January 3, 2017 through January 3, 2018, should return the product to place of purchase for full refund. Customers may also contact Evershing International Trading Company at (408) 975-9660 during hours of operation, Monday to Saturday from 9:00 am to 5:00 pm.

    The issue was discovered by testing performed by the State of Massachusetts.

    This voluntary recall is being made with the knowledge of the US Food and Drug Administration. We appreciate your assistance in this matte. Although these products are not ready-to-eat items and have baking instructions which, if followed, will reduce consumer risk, there remains some risk that the mishandling of this product prior to or without adequate baking may cause illness.

    We are working in coordination with the Food and Drug Administration (FDA) and our supplier on this recall.

    All affected distributors and retail customers are being notified and the affected products are being removed from store shelves.

    Affected product should be destroyed or may be returned to the place of purchase for a full refund. Consumers with questions may contact 1-866-837-2758 between 8 a.m. and 5 p.m. Eastern Time.

AuroMedics Pharma LLC is voluntarily recalling lot AFO l 17001-A, Expiry date Dec 2018, of Ampicillin and Sulbactam for Injection USP, 1.5 g (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium salt) in a Single-Dose vial, to the hospital level. The product has been found to contain glass particles.

Risk Statement: The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening.

The product Ampicillin and Sulbactam for Injection is used for treatment of infections due to susceptible strains of designated microorganism in skin and skin structure infections, intra­abdominal infections and gynecological infections in adults and for in treatment of skin and skin structure infection in pediatric patient one year and older. The affected Ampicillin and Sulbactam for Injection lot being recalled is AFO l 17001, EXP. December 2018. It is packaged in a carton containing 10 vials, NDC: 55150-116-20. The product can be identified as a ‘clear vial stoppered with grey rubber stopper and sealed with aluminum seals having a Royal Blue color polypropylene disc’. AuroMedics shipped the entire lot to wholesalers and/or hospitals nationwide on February 9, 2017.

To date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to the product.  Consumers with questions regarding this recall can contact AuroMedics Customer Service Monday through Friday from 9:00AM to 5:00PM EST at 888-238-7880 Option 1. If you need assistance in returning your product or have questions about the recall process, contact Inmar at 800-967-5952, Monday through Friday from 8:30 AM to 5:00 PM EST. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

  • 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

FDA/USDA ~ Dec Alerts & Safety pg2


  •  Updated information is now available. A list of retail consignees has been posted for recall 131-2017, Swift Beef Company Recalls Beef Stew Products Due to Possible Foreign Matter Contamination (Dec 26, 2017).     Swift Beef Company Recalls Beef Stew Products Due to Possible Foreign Matter Contamination Swift Beef Co., doing business as JBS USA Food Company, a Cactus, Texas establishment, is recalling approximately 4,702 pounds of beef stew product that may be contaminated with foreign matter , specifically plastic and metal.
  • AuroMedics Pharma LLC is voluntarily recalling one lot of Linezolid Injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007 expiration August 2018 to the hospital level. This batch was distributed May 15 through August 14, 2017. The product was found to contain white particulate matter that has been identified as mold. This problem was discovered as a result of a product complaint in which the contents of one flexible bag from one batch CLZ160007 was found to contain white particulate matter.

    Use of a non-sterile injectable product could result in fatal infections in a broad array of patients. To date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to this recall.

  • Nodine’s Smokehouse, Inc. of Torrington, Connecticut is recalling Smoked Salmon 1.5 lbs, 8 oz packages. Lot numbers 40173 and 33173 because they have the potential to be contaminated with Listeria monocytogenes. Consumption of food contaminated with Listeria monocytogenes can cause listeriosis, with high fever, severe headache, neck stiffness, and nausea as its primary symptoms. In rare cases, listeriosis is fatal; it can also cause miscarriages and stillbirths. People experiencing these problems should seek immediate medical attention. Pregnant women the very young, elderly, and persons with compromised immune systems are
    the most susceptible.The Smoked Salmon was distributed nationwide in retail stores and through mail orders. The product comes in 1.5 lb and 8 oz packages with lot numbers 40173 and 33173.
  • PFP Enterprises LLC Recalls Ground Beef Products Due to Misbranding and An Undeclared AllergenPFP Enterprises LLC, also doing business as Texas Meat Packers, a Fort Worth, Texas establishment, is recalling approximately 7,570 pounds of ground beef products due to misbranding and an undeclared allergen.
  • As a result of the Fresh-Pak Inc. recall, Meijer is announcing a voluntary recall of select Meijer brand packaged products due to sliced apples within the products being potentially contaminated with Listeria monocytogenes. To date, there have been no known illnesses reported in connection with this recall.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, including animals. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, a Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women.The following Meijer brand packaged products contain apple slices that were supplied by Detroit-based Fresh-Pak, Inc. Meijer received notice of a possible Listeria monocytogenes contamination from Fresh-Pak, which was alerted by their supplier, Jack Brown. The recalled product will be in plastic containers with printed labels and include “sell by” range of December 17, 2017 through December 21, 2017.    The products were sold in Meijer stores in Michigan, Ohio, Indiana, Illinois, Kentucky and Wisconsin.  Customers should stop using the product and either dispose of it, or return it to the customer service desk at any Meijer store for a full refund. For additional information, please contact Meijer at (800) 543-3704, available 24 hours a day, seven days a week. Meijer stores are opened 24 hours a day, seven days a week.
  • East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial, to the hospital level. The product was found to contain glass particles in the vial.  This problem was discovered as a result of a product complaint in which the contents of one vial from one batch was found to contain a piece of glass.The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening. To date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to this recall.Pantoprazole Sodium for Injection 40 mg per vial, is used for short term treatment of gastroesophageal reflux disease associated with a history of erosive esophagitis and pathological hypersecretion including zollinger-ellison syndrome and is packaged in a carton containing 10 vials, NDC: 55150-202-10. The affected Pantoprazole Sodium for Injection lot being recalled is CPO170035, EXP. May 2019. The product can be identified as ‘vial stoppered with grey slotted rubber stopper and sealed with aluminum seals having Sky Blue color polypropylene disc’. AuroMedics commenced shipping the product to customers on August 7, 2017 and was distributed to wholesalers and/or hospitals nationwide.AuroMedics Pharma LLC is notifying its distributors and customers by recall letters and is arranging for return/replacement etc. of all recalled product. Consumers/distributors/retailers that have the product lot which is being recalled should immediately stop using and return to place of purchase/contact their doctor as appropriate.Consumers with questions regarding this recall can contact Aurobindo Customer Service weekdays 9:00AM to 5:00PM EST at 866-850-2876 Option 1.  If you need assistance in returning your product or have questions about the recall process, contact Inmar at 800-967-5952 weekdays Monday through Friday 8:30 AM to 5:00 PM EST. 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.

    This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

  • Springfield Smoked Fish of Springfield, MA is expanding their voluntary recall of smoked fish products because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious 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, Listeriainfection can cause miscarriages and stillbirths among pregnant women.Recalled products were distributed and sold at retail stores and wholesale establishments in Massachusetts, Connecticut, New York, Rhode Island, Colorado, Ohio, Pennsylvania from May 2017 through December 2017. Product was also sold nationwide through online sales.The initial recall was limited to 1lb pre-sliced Nova Salmon produced on 11/24/17. The recall expansion includes product produced between May 22, 2017 and December 12, 2017, the date the facility ceased production of the products.These products were sold under the brand names Springfield Smoked Fish and Rachael’s Springfield Smoked Fish.No illnesses have been reported to date in connection with this problem.The recall expansion was initiated as a result of environmental and product sampling conducted by the firm. Springfield Smoked Fish is committed to ensuring consumer safety and providing quality products and ingredients to customers.  The company is working diligently to determine the root cause and continues working with food safety experts to implement corrective actions and preventative measures.Retailers and wholesale customers should check their inventories and shelves to confirm that none of the recalled products are present or available for purchase by consumers or in warehouse inventories.  Please contact Springfield Smoked Fish for disposal or return of the product.Consumers are urged not to consume these products. Consumers who purchased these products may take them back to the store where they purchased them for a refund or simply discard them. Consumers with questions may contact the company at 1-413-737-8693, Monday through Friday 8:00 am – 4:00 pm.