- Belmont Sausage Co. Recalls Smoked Turkey Drumstick Products Due To Misbranding and Undeclared AllergensBelmont Sausage Co., an Elk Grove Village, Ill. establishment, is recalling an undetermined amount of smoked turkey products due to misbranding and undeclared allergens.
- America New York RI Wang Food Group Recalls Sausage Products Due To Misbranding and an Undeclared Allergen America New York RI Wang Food Group, a Maspeth, N.Y. establishment, is recalling approximately 63,823 pounds of Heat Treated but Not Fully Cooked-Not Shelf Stable pork sausage products and beef products due to misbranding and an undeclared allergen.
- King Soopers said today it has recalled its chicken salad sandwiches that are sold in King Soopers and City Market stores, located in Colorado, Utah, New Mexico and Wyoming. The product may be contaminated with Listeria monocytogenes.
- Updated information is now available. A list of retail consignees has been posted for recall 097-2017, Ronald A. Chisholm, Ltd. Recalls Pork Belly Products Produced Without Benefit of Import Inspection (Aug 26, 2017).
- Updated information is now available. A list of retail consignees has been posted for recall 092-2017, Luvo Inc. (USA) Recalls Poultry Products Due To Misbranding and Undeclared Allergens (Aug 12, 2017).
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Death Wish Coffee Co. Announces Recall of Nitro Cold Brew Cans From Retailers, Online Sales
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Natures Supplement, Inc. is voluntarily recalling 260 bottles of VEGETABLE VIGRA, 200 mg capsules to the consumer level. FDA analysis found this product to be tainted with Sidenafil. Sildenafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of Sildenafil in the Vegetable Vigra product renders it an unapproved drug for which safety and efficacy has not been established, therefore subject to recall. -
Newark, CA, Gadget Island, Inc. is voluntarily recalling to the consumer level. The products have been found to contain undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil. - Rhino 7 Platinum 5000, UPC 617135861224, LOT# R7-D5K1011H
- Papa Zen 3000, UPC 718122032587, LOT# NSS050888
- Fifty Shades 6000, UPC 4026666146056, LOT# No Lot Number
- Grande X 5800, UPC 640793555440, LOT# No Lot Number
Risk Statement: Use of products with undeclared active ingredients sildenafil, tadalafil and desmethyl carbodenafil may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are the most at risk from these products.
- Updated information is now available. A list of retail consignees has been posted for recall 097-2017, Ronald A. Chisholm, Ltd. Recalls Pork Belly Products Produced Without Benefit of Import Inspection (Aug 26, 2017).
- You are subscribed to FSIS Recall Cases: Retail Lists for the USDA Food Safety and Inspection Service. Updated information is now available. A list of retail consignees has been posted for recall 101-2017, America New York RI Wang Food Group Recalls Sausage Products Due To Misbranding and an Undeclared Allergen (Sep 15, 2017).
- German Sausage Haus, LLC, Recalls Meat Products Due To Possible Processing Deviation and Staphylococcal Enterotoxin Contamination
German Sausage Haus, LLC, a Camano Island, Wash., establishment, is recalling approximately 1,252 pounds of Heat Treated, Not Fully Cooked-Not Shelf Stable (HTNFCNSS) meat products due to a possible processing deviation that may have led to staphylococcal enterotoxin contamination. - America New York RI Wang Food Group Recalls Sausage Products Due To Misbranding and an Undeclared Allergen
America New York RI Wang Food Group, a Maspeth, N.Y. establishment, is recalling approximately 53,973 pounds of Heat Treated but Not Fully Cooked-Not Shelf Stable pork sausage products due to misbranding and an undeclared allergen - Inspection Program For Siluriformes Fish, Including Catfish for USDA Food Safety and Inspection Service. The topic has recently been updated and new information is now available.
- Updated – Operations/Inspections, International Affairs: Importing and Exporting, FSIS published a letter to exporters of Siluriformes fish products providing guidance: Letter
- This information has recently been updated, and is now available. Having trouble viewing this email? View it as a Web page. https://content.govdelivery.com/accounts/USFSA/bulletins/1b6e10e
09/13/2017 04:30 PM EDTWASHINGTON, Sept. 13, 2017 – Agriculture Secretary Sonny Perdue today announced special procedures to assist producers who lost crops or livestock or had other damage to their farms or ranches as a result of hurricanes Harvey and Irma. Also, because of the severe and widespread damage caused by the hurricanes, USDA will provide additional flexibility to assist farm loan borrowers.
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09/12/2017 03:20 PM EDTMedtronic plc (NYSE:MDT) announced today that it has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors.
- Bravo Produce Inc. Retira Maradol Papaya de Productores y Exportadores de Carica Papaya de Tecomán y Costa Alegre SPR de RL y empacadas por Frutas Selectas de Tijuana, S. de R.L. de C.V. Por posible riesgo a la salud09/12/2017 11:56 AM EDT Bravo Produce Inc de San Ysidro, está retirando Maradol Papaya, cultivadas por Productores y Exportadores de Carica Papaya de Tecoman y Costa Alegre SPR de RL y empacadas por Frutas Selectas de Tijuana, S. de R.L. de C.V., como manera preventiva, debido a que dicho producto ha probado positivo para Salmonella, es de suma importancia mencionar que dicha bacteria puede afectar a niños, ancianos y personas con sistemas inmunológicos débiles. Los síntomas a experimentar son fiebre, diarrea, náusea, vómito y dolor abdominal. En raras circunstancias, la infección por Salmonella puede resultar en el organismo entrando en el torrente sanguíneo y la producción de enfermedades graves, como las infecciones arteriales (es decir, los aneurismas infectados), endocarditis y artritis.
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09/10/2017 04:14 PM EDTBravo Produce Inc. of San Ysidro, is withdrawing Maradol Papaya, grown by Productores y Exportadores de Carica Papaya de Tecomán y Costa Alegre SPR of RL and packed by Frutas Selectas de Tijuana, S. de RL de CV, as a preventive measure, because the product has tested positive for Salmonella by exams done by FDA. It is extremely important to mention that this bacterium can affect children, elderly and people with weak immune systems. Symptoms are fever, diarrhea, nausea, vomiting and abdominal pain.
- Updated information is now available. A list of retail consignees has been posted for recall 100-2017, Northside Noodle Company Recalls Meatball Products Due To Misbranding and Undeclared Allergens (Sep 8, 2017).
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09/08/2017 07:52 PM EDTSimply Fresh Foods, Inc. of Buena Park, CA is recalling 272 cases of one specific lot of its 4-4 ounce packages of “San Francisco Seafood Salad Made with Greek Yogurt” bearing a UPC bar code of 47502 19701 because the individual cups inside the carton may be mislabeled as Seafood Salad with Real Mayonnaise and does not declare “milk”. The outer carton is correct and has the correct ingredient statement which declares “milk”. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
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09/08/2017 02:02 PM EDTNorthside Noodle Company, an Iron Mountain, Mich., establishment, is recalling approximately 123 pounds of meatball products due to misbranding and undeclared allergens (soy)
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09/08/2017 09:49 AM EDTToday, Garden of Life, LLC, is issuing a voluntary precautionary recall of its new supplement for infants, Baby Organic Liquid, because the product, as labeled, includes directions for use that may be misinterpreted. The company is concerned that if not administered precisely following the labeled instructions, the product may present difficulties in swallowing and potentially pose a choking hazard due to the thickness of the liquid.
- Updated information is now available. A list of retail consignees has been posted for recall 099-2017, Demakes Enterprises, Inc. Recalls Chicken Sausage Product Due To Misbranding and Undeclared Allergens (Aug 30, 2017)
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09/05/2017 11:40 AM EDTCountry Fresh Orlando, LLC. of Orlando, Florida, is recalling 5,999 cases of diced bell pepper, vegetable kabobs, and creole and fajita mixed diced vegetables (product descriptions attached), because they have the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
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Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication – FDA Recommends Separating Dosing
AUDIENCE: Internal Medicine, Nephrology, Cardiology, Pharmacy
ISSUE: FDA is recommending that patients avoid taking the potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) at the same time as other medicines taken by mouth. A study found that sodium polystyrene sulfonate binds to many commonly prescribed oral medicines, decreasing the absorption and therefore effectiveness of those oral medicines. To reduce this likelihood, we recommend separating the dosing of sodium polystyrene sulfonate from other orally administered medicines by at least 3 hours. We are updating the sodium polystyrene sulfonate drug labels to include information about this dosing separation.
- Wakefern Food Corp. Voluntarily Recalls ShopRite Semi-Sweet Real Chocolate Chips
Wakefern Food Corp. has initiated a voluntary recall of its ShopRite brand Semi-Sweet Real Chocolate Chips. The chips were sold in 24 oz. bags bearing a UPC bar code of 041190 02668 and Best if Used By dates of April 11, 2019 and April 12, 2019. - Updated information is now available. A list of retail consignees has been posted for recall 095-2017, Expresco Foods Inc. Recalls Chicken Skewer Products Due to Possible Listeria Contamination (Aug 23, 2017)
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09/01/2017 03:15 PM EDTPharMEDium Services, LLC (PharMEDium) is voluntarily recalling all unexpired lots of Oxytocin compounded with Lactated Ringers and all unexpired lots of Oxytocin compounded with Lactated Ringers and Dextrose products that were produced between July 6, 2017 and August 29, 2017 to the hospital/user level. The recall is being issued based on laboratory test results indicating a lower than expected potency on certain lots of Oxytocin compounded with Lactated Ringers and Oxytocin Compounded with Lactated Ringers and Dextrose which would lead to a lower dose being administered.
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09/01/2017 10:22 AM EDTHospira, Inc., a Pfizer company, is voluntarily recalling one lot of Hydromorphone HCI Injection, USP, CII (2 mg/mL) 1mg/mL Vial and four lots of Levophed® (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial due to a potential lack of sterility assurance resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. To date, Hospira, Inc., a Pfizer company has not received any reports of adverse events related to this recall.
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09/01/2017 07:10 PM EDTWakefern Food Corp. has initiated a voluntary recall of its ShopRite brand Semi-Sweet Real Chocolate Chips. The chips were sold in 24 oz. bags bearing a UPC bar code of 041190 02668 and Best if Used By dates of April 11, 2019 and April 12, 2019.
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Alcohol Pads or Benzalkonium Chloride Antiseptic Towelettes by Foshan Flying Medical Products: FDA Alert – Lack of Sterility Assurance and Other Quality Issues
AUDIENCE: Pharmacy, Health Professional, Patient
- ISSUE: The U.S. Food and Drug Administration is alerting health care professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes made by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues. These products are distributed by Total Resources International, Walnut, California, and Simple Diagnostics Inc., Williston Park, New York. The use of these alcohol pads and antiseptic towelettes could cause infections
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09/01/2017 03:15 PM EDTPharMEDium Services, LLC (PharMEDium) is voluntarily recalling all unexpired lots of Oxytocin compounded with Lactated Ringers and all unexpired lots of Oxytocin compounded with Lactated Ringers and Dextrose products that were produced between July 6, 2017 and August 29, 2017 to the hospital/user level. The recall is being issued based on laboratory test results indicating a lower than expected potency on certain lots of Oxytocin compounded with Lactated Ringers and Oxytocin Compounded with Lactated Ringers and Dextrose which would lead to a lower dose being administered.
- Updated information is now available. A list of retail consignees has been posted for recall 095-2017, Expresco Foods Inc. Recalls Chicken Skewer Products Due to Possible Listeria Contamination (Aug 23, 2017)
- Hospira Issues Voluntary Worldwide Recall For Lots of Hydromorphone HCl Injection, USP, CII, (2 mg/mL) 1mg/mL Vial, and Levophed® (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial, Due to a Lack of Sterility Assurance 09/01/2017 10:22 AM EDT Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Hydromorphone HCI Injection, USP, CII (2 mg/mL) 1mg/mL Vial and four lots of Levophed® (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial due to a potential lack of sterility assurance resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. To date, Hospira, Inc., a Pfizer company has not received any reports of adverse events related to this recall.
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Keytruda (pembrolizumab) in Patients with Multiple Myeloma: FDA Statement – Two Clinical Trials on Hold
AUDIENCE: Oncology ISSUE: Based on data from two recently halted clinical trials, the U.S. Food and Drug Administration today is issuing this statement to inform the public, health care professionals, and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. Keytruda (pembrolizumab) is not approved for treatment of multiple myeloma.
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