- Silver Star Brands, Inc., is initiating a voluntary recall of six products for humans (including four Native Remedies® and two Healthful Naturals™) and two PetAlive® products for pets for a total of eight products with lot numbers, see table below, to the consumer level. The products have been tested and found to contain microbial contamination.Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention and could result in infections that could be life threatening to certain individuals and animals. To date, Silver Star Brands, Inc. has not received any reports of adverse events related to this recall.These products can be identified by the main label on the bottle and the lot number that is printed on the label. Each product recalled is an individual 2 oz. oral spray in amber bottle (see table below), manufactured at the King Bio, Inc. facility in Asheville, NC. Product was distributed nationwide via wholesale, retail and online sales. Native Remedies®, PetAlive® and Healthful Naturals™ package images for products affected are attached (below).
HUMAN PRODUCTS PRODUCT INDICATION NDC UPC LOT EXPIRATION DATE Native Remedies VertiFree oral spray Temporary relief for dizziness and nausea 68703-253-02 818837012260 K061417B 6/20 Native Remedies VaricoGo oral spray Relieves discomfort associated with varicose veins 68703-105- 59 818837010419 K111717A 11/20 Native Remedies HypoSlim oral spray Assists with healthy weight management and metabolism 68703-275- 02 818837013724 K051818A 05/21 Native Remedies EyeClear Pro oral spray Relieves symptoms of mineral buildup and eye irritation 68703-151- 59 818837011652 K022317A, K022317B 02/20 Healthful Naturals DizziFree oral spray Temporarily relieves dizziness and nausea 68703-204- 02 840853166535 K022616D N/A Healthful Naturals Leg Cramp Support Temporary relief from cramps and spasms while resting 68703-206- 02 840853166559 K022216C N/A PET PRODUCTS PRODUCT INDICATION NDC UPC LOT EXPIRATION DATE PetAlive Plump-Up Pet oral spray Improves appetite in underweight dogs and cats 68703-290- 02 818837013908 K011617E 01/20 PetAlive Allergy Itch Ease oral spray Relieves skin itch 68703-135- 59 818837011102 K111617B 11/20 Silver Star Brands, Inc. is notifying its distributors and customers by letter and is arranging for return and replacement (or refund) of the recalled products.
Consumers/distributors/retailers that have this product which is being recalled should discontinue use/distribution and contact Silver Star Brands, Inc.
at Nativeremedies@silverstarbrands.com to make arrangements to return the product. These
products were distributed nationwide to retailers (doctor offices, pharmacies, health food stores) and consumers (direct sales and website).Consumers with questions regarding this recall can contact Silver Star Brands, Inc. at 1-888- 736-6389 Monday – Friday 8:00 am – 5:00 pm CST or email Nativeremedies@silverstarbrands.com. Consumers should contact their physician or healthcare provider if they believe they have experienced any problems that may be related to using this product.
Adverse reactions or quality problems associated with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form 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.
The Center for Veterinary Medicine recommends calling the drug company to report adverse drug experiences or product defects for FDA-approved animal products. The drug company responsible for the approved product is required to submit these reports to FDA. Call1-888-736- 6389.
- If you prefer to report directly to the FDA, you can submit Form FDA 1932a by following the link to the form found at https://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm and following the instructions for emailing the completed form to FDA.
- If you have a question about ADE reporting or need a paper copy of the form, contact CVM by email at AskCVM@fda.hhs.gov or by phone at 1-888-FDA-VETS (1-888-332-8387).
- Johnston County Hams Recalls Ready-To-Eat Ham Products Due to Possible Listeria ContaminationJohnston County Hams, a Smithfield, N.C. establishment, is recalling approximately 89,096 pounds ofready-to-eat ham products that may be adulterated with Listeria monocytogenes
- JBS Tolleson, Inc. Recalls Raw Beef Products Due to Possible Salmonella Newport ContaminationJBS Tolleson, Inc., a Tolleson, Ariz. establishment, is recalling approximately 6,500,966 pounds of various raw, non-intact beef products that may be contaminated with Salmonella Newport.
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Human and Animal Drug Products by Silver Star Brands: Recall – Due to Microbial Contamination was just added to the FDA Recalls webpage.You can read the complete recall alert at: https://www.fda.gov/Safety/Recalls/ucm622488.htm
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Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label was just added to the FDA Recalls webpage.You can read the complete recall alert at: https://www.fda.gov/Safety/Recalls/ucm622008.htm
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Oscor Inc. Issues Recall of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models) was just added to the FDA Recalls webpage.You can read the complete recall alert at: https://www.fda.gov/Safety/Recalls/ucm621931.htm
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09/24/2018 Mauna Loa Macadamia Nuts E. coli - Asian Fusion Cookies (September 12, 2018)
Sarap Asian Fusion recalls four flavors of Asian Fusion Cookies due to undeclared allergens of wheat, milk, and soy.
Asian Fusion Cookies allergen recall press release and product labels.
- Chicken Products – Diced, Grilled, Strips (September 5, 2018)
Wayne Farms, LLC recalls frozen, fully cooked chicken products that may be contaminated with metal pieces. The products have the establishment number “P-20214” inside the USDA mark of inspection. These items were shipped to distributors, restaurants, and further processing locations nationwide.
Chicken Products recall news release and product labels.
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DERBY CITY CHICKEN SALAD WITHOUT WALNUTS, 15.00 OZ Affects Kroger stores located in Greater Cincinnati (including Northern Kentucky and Dayton, Ohio plus South Eastern Indiana);
Reason: The product may contain WALNUTS and, if eaten, could result in severe allergic reactions to those persons sensitive to WALNUTS.
Click here for more information.
Recalled on September-4-2018.
- Updated information is now available. The lists of retail consignees have been posted for recalls:
- Updated information is now available. The lists of retail consignees have been posted for recalls:
- Zweigle’s Inc. Recalls Olive Loaf Pork Products due to Sodium Nitrite Levels in Excess of Regulatory LimitZweigle’s Inc., a Rochester, N.Y., establishment, is recalling approximately 6,082 pounds of ready-to-eatolive loaf pork products due to sodium nitrite levels in excess of the regulatory limit.
- Junior’s Smokehouse Processing Plant Recalls Beef Jerky Products due to Possible Foreign Matter ContaminationJunior’s Smokehouse Processing Plant, an El Campo, Texas establishment, is recalling approximately 690 pounds of ready-to-eat teriyaki beef jerky products that may be contaminated with extraneous materials, specifically pieces of hard metal.
- Cargill Meat Solutions Recalls Ground Beef Products Due To Possible E. Coli O26 ContaminationCargill Meat Solutions, a Fort Morgan, Colo. establishment, is recalling approximately 132,606 pounds of ground beef products made from the chuck portion of the carcass that may be contaminated with Escherichia coli O26.
- McCormick & Company, Inc. is initiating a voluntary recall of Meijer Taco Seasoning Mix 4.5 OZ bottle due to an unlabeled milk allergen.This recall does not impact any other sizes of Meijer Taco Seasoning.To date, Meijer has not reported any allergic reactions related to this product. In sensitive individuals, products containing milk can cause illness or severe reactions.Recalled Product: Meijer Taco Seasoning Mix 4.5 OZ BottleUPC# 719283494290
Best By Dates:
* AUG 04 20 H
* AUG 05 20 HSTATES SHIPPED TO: MI, KY, IN, IL, OH, WI
McCormick has alerted Meijer Foods to remove the product with the affected date codes from store shelves and distribution centers immediately, and to destroy this product in a manner that would prevent further consumption.
Consumers do not need to return the product to the store where it was purchased. Instead, consumers are urged to dispose of the recalled product and its container. Please contact Consumer Affairs at 1-800-632-5847, weekdays from 9:30 AM to 7:00 PM (Eastern Time) with inquiries.
- Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.Administration of a non-sterile product that is intended to be sterile by subcutaneous, intramuscular, intravenous or ocular routes of administration may result in serious injury or death. The pharmacy has not received any reports of patient complaints or adverse events related to this recall. To date, Pharm D Solutions, LLC is not aware of any adverse events related to this recall. Nor is there any indication that the compounded sterile drug products being recalled are actually contaminated. No medications or any component thereof have been shown to be non-sterile. This voluntary recall is being conducted out of an abundance of caution and to promote patient safety, which is the pharmacy’s highest priority.The recall encompasses all compounded sterile drug products, within expiry, that were dispensed within the last twelve months. The sterile drug products subject to this recall were distributed nationwide and directly to customers and/or medical facilities. The recall does not affect the pharmacy’s non-sterile compounded products or retail pharmacy operations.The pharmacy has notified potentially affected customers of the voluntary recall via U.S. Mail and direct outreach. Customers who have received sterile compounded products subject to the voluntary recall should stop using and return the product to the pharmacy for a full refund.Consumers with questions regarding this recall can contact Pharm D Solutions, LLC by calling Luis R DeLeon or Carlos DeLeon at 713-790-1693, Monday through Friday between 9:00 a.m. and 5:00 p.m., CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.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.
- Complete and submit the report Online: http://www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form 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
- Bravo Packing, Inc. Recalls Performance Dog Raw Pet Food Because of Possible Salmonella Health Risk to Humans and Animals
Bravo Packing, Inc. of Carneys Point, NJ is recalling all Performance Dog products, a frozen raw pet food, because it has the potential to be contaminated with Salmonella. Salmonella can cause illness in animals eating the products, as well as people who handle contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products, infected animals or any surfaces exposed to these products. Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis (an infection of the heart muscle), arthritis, muscle pain, eye irritation and urinary tract symptoms.
- Roya Foods, LLC Recalls Halal Manti Beef Dumpling Products Produced Without Benefit of InspectionRoya Foods, LLC, a Paterson, N.J., distribution firm, is recalling approximately 438 pounds of raw Halal Manti Beef Dumpling products that were produced without the benefit of federal inspection.
- Bob Evans Farms Inc. Recalls Pork Sausage Link Products Due to Possible Foreign Matter ContaminationBob Evans Farms, Inc., a Xenia, Ohio, establishment, is recalling approximately 46,734 pounds of pork sausage link products that may be contaminated with extraneous materials, specifically pieces of clear hard plastic.
- CTI Foods LLC Recalls Ready-To-Eat Philly Steak Products Due to Possible Listeria ContaminationCTI Foods LLC, an Owingsville, Ky., establishment, is recalling approximately 6,720 pounds of ready-to-eat (RTE) Philly Beef Steak products that may be adulterated with Listeria monocytogenes.
- Gravel Ridge Farms is recalling Cage Free Large Eggs due to a potential contamination of Salmonella. The recall was initiated because reported illnesses were confirmed at locations using Gravel Ridge Farm Eggs, and we are voluntarily recalling out of an abundance of caution.Salmonellais 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.On 9/6/2018 the firm was notified by FDA that the product they supplied may be contaminated with Salmonella. Products affected are:
Product Size UPC Use By Dates Gravel Ridge Farms
Large Cage Free EggsSingle Dozen and 2.5 Dozen Flats 7-06970-38444-6 7/25/18 through 10/3/18 The products were distributed between 6/25/2018 and 9/6/2018. These products were packaged in a cardboard container and sold primarily in restaurants and retail stores in AL, GA, and TN. Consumers who have purchased these products can return to store for refund or discard the product immediately. If any consumers have Gravel Ridge Farms eggs in their refrigerator, they should be discarded, regardless of the date stamped on the package. Consumers with questions may call Dustin Smith at 205-363-1105 M-F Between 8AM and 4PM Central Time.
The following retail stores carried the product:
Atlanta
Candler Park Market
Grant Park Market
Westview Corner Market
Sevananda Natural Foods
The Merchantile
Birmingham
Piggly Wiggly Clairemont
Piggly Wiggly River Run
Piggly Wiggly Crestline
Piggly Wiggly Bluff Park
Piggly Wiggly Dunnavent Valley
Piggly Wiggly Warrior
Piggly Wiggly Homewood
Western Market Mt. Brook
Western Market Rocky Ridge
Foodland Eva
Warehouse Discount Grocery Hanceville
Warehouse Discount Grocery Cullman 2 locations
Foodland Priceville
Star Market Huntsville
Manna Grocery Tuscaloosa
The company has ceased the production and distribution of the product as FDA and the company continue their investigation as to what caused the problem.
This recall is being made with the knowledge of the Food and Drug Administration.
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Homeopathic Aqueous/Alcohol-Based Medicines by Beaumont Bio Med: Recall – Due to Possible Microbial Contamination was just added to the FDA Recalls webpage.You can read the complete recall alert at: https://www.fda.gov/Safety/Recalls/ucm619587.htm
- Beaumont Bio Med, Inc. is voluntarily recalling its entire aqueous/alcohol-based product line for human use, within expiry, to the consumer level. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.Risk Statement: The administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to certain individuals. To date, Beaumont Bio Med has not received any reports of adverse events related to this recall.The products being recalled are listed in this table:
Products Name Size/Packaging/Dosage Form NDC Number Lot Number Expire Date Skin Irritation & Itch Response 2 Fl Oz, Amber Glass, Oral Spray 58066 7002 7 091515C 09/2018 Skin Irritation & Itch Response 2 Fl Oz, Amber Glass, Oral Spray 58066 7002 7 050118S 05/2021 Sinus Response 2 Fl Oz, Amber Glass, Oral Spray 58066 7013 7 100316A 10/2109 SoreThroat & Laryngitis Response 2 Fl Oz, Amber Glass, Oral Spray 58066 7014 7 100316G 10/2019 SoreThroat & Laryngitis Response 2 Fl Oz, Amber Glass, Oral Spray 58066 7014 7 050118R 05/2021 Diarrhea Response 2 Fl Oz, Amber Glass, Oral Spray 58066 7022 7 090915 09/2018 Muscle & Joint Pain Relief 2 Fl Oz, Amber Glass, Oral Spray 58066 7041 7 012916F 01/2019 Allergy & Hay Fever Relief 2 Fl Oz, Amber Glass, Oral Spray 58066 7011 7 050216X 05/2019 Cold & Flu Response 2 Fl Oz, Amber Glass, Oral Spray 58066 7012 7 042816C 04/2019 Cold & Flu Response 2 Fl Oz, Amber Glass, Oral Spray 58066 7012 7 112317K 11/2020 Arthritis Pain Relief 2 Fl Oz, Amber Glass, Oral Spray 58066 7042 7 112317K 01/2019 Beaumont Bio Med Homeopathic Medicines are distributed Nationwide in the USA to wholesalers, health professionals and retail establishments and on our website www.naturalief.com
Beaumont Bio Med is notifying its distributors and customers by email and/or phone and is arranging for return/replacement/refund of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using, discard or return to place of purchase for replacement or refund.
Consumers with questions regarding this recall can contact Beaumont Bio Med by phone : 800-332-2249 or e-mail: recall@naturalief.com on Monday – Friday from 8:30AM to 4:00PM, CDT. 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 associated with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form 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.
- Updated information is now available. The lists of retail consignees have been posted for recalls:
- Caito Foods, LLC Recalls Chicken Salad Products due to Misbranding and an Undeclared AllergenCaito Foods, LLC., an Indianapolis, Ind. establishment, is recalling approximately 242 pounds of fully cooked chicken salad product due to misbranding and an undeclared allergen.
- Wayne Farms, LLC Recalls Fully Cooked Chicken Products due to Possible Foreign Matter ContaminationWayne Farms, LLC, a Decatur, Ala. establishment, is recalling approximately 438,960 pounds of frozen, fully cooked chicken products that may be contaminated with extraneous materials, specifically metal pieces
- New York Style Sausage Co. Recalls Raw Chorizo Sausage Products due to Misbranding and an Undeclared IngredientNew York Style Sausage Co., a Sunnyvale, Calif. establishment, is recalling approximately 371 pounds of raw chorizo sausage products due to misbranding.
- H&C Food Inc of Brooklyn, NY is recalling the Frozen Fuzhou Fish Balls and the Fish Balls, because they may contain undeclared wheat, pork, egg, and crustacean. People who have an allergy or severe sensitivity to wheat, pork, egg and crustacean run the risk of serious or life-threatening allergic reaction if they consume these products.The Fuzhou Fish Balls and the Fish Balls was distributed to supermarkets in Queens, NY and reached consumers mainly through the retail stores.The recalling Frozen Fish Balls came with two different packages. First, the frozen fish balls are in the red and white plastic bag with gold and black font that are written Fish Balls and the size for this is NET WT: 14OZ (400g), UPC: 6 953006 4 50093. The Fuzhou Fish Balls are in the blue and white plastic bag with gold and white font that are written Fuzhou Fish Balls and there are two sizes: Net WT: 14 OZ (400g), UPC: 6 953640 050017 and Net WT:4.5 lbs. (2043g), UPC: 6 953640 05000. These Frozen Fish Balls don’t have the expiration date or lot code on the package, however, they can last for 18 months.There are no illnesses have been reported to date.The recall was initiated after it was discovered that product containing wheat, pork, egg and crustacean were distributed in packaging that did not reveal the presence of egg and crustacean. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s production and packaging processes.Consumers who have purchased frozen fish balls are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-718-821-5188, from Monday – Friday 9 a.m. to 5 p.m.
- Bahar LLC Recalls Frozen, Raw Beef Dumpling Products Produced without Benefit of Inspection Bahar LLC., a Clifton, N.J. establishment, is recalling approximately 2,344 pounds of frozen, raw beef dumplings products that were produced without the benefit of federal inspection.
- J.T.M. Provisions Company Recalls Cooked Ground Beef Products Due To Possible Listeria Contamination J.T.M. Provisions Co., a Harrison, Ohio establishment, is recalling approximately 960 pounds of cooked ground beef patty products that may be adulterated with Listeria monocytogenes.
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