Month: November 2019

Summary

Company Announcement Date:
November 14, 2019
FDA Publish Date:
November 14, 2019
Product Type:
Animal & Veterinary
Pet Food
Beef/Beef Product
Reason for Announcement:
May be contaminated with Salmonella
Company Name:
Go Raw, LLC
Brand Name:
Quest
Product Description:
Beef Cat Food

Company Announcement

Go Raw, LLC, of Cottonwood Utah is recalling its 2lb. frozen bags of “Quest Beef Cat Food” because they may be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products 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, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

The affected products were nationally distributed through retail stores and are identified with the following UPC 6-91730-17101-8, Lot N128.

No illnesses have been reported to date in connection with this problem. (more…)

Class I Recall113-2019
Health Risk: HighNov 15, 2019

Congressional and Public Affairs
Mitch Adams
(202) 720-9113
FSISpress@usda.gov

 

EDITOR’S NOTE: FSIS and our public health partners, including the Centers for Disease Control and Prevention (CDC) and state public health officials, are investigating a Salmonella Dublin outbreak. Please note that FSIS is continuing to investigate illnesses associated with this outbreak and their sources and additional product may be recalled.

WASHINGTON, Nov. 15, 2019 – Central Valley Meat Co., Inc., a Hanford, Calif. establishment, is recalling approximately 34,222 pounds of ground beef products that may be contaminated with Salmonella Dublin, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The ground beef items were produced on July 23, 2019. The following products are subject to recall: [View Labels (PDF only)]

  • 1-lb. chub packages of “STATER BROS. 100% PURE GROUND BEEF 96% LEAN 4% FAT” with lot 2049 on the retail label; lot 19204 on the case label; and Use By 08-14-19.
  • 2-lb. chub packages of “STATER BROS. 100% PURE GROUND BEEF 93% LEAN 7% FAT” with lot 2049 on the retail label; lot 19204 on the case label; and Use By 08-14-19.
  • 20-lb. cases containing “STATER BROS 93/7 Ground Beef 10# Chub 10 Lb. Chubs/ 2 Count” with lot 19204 on the case label and Use By 08-14-19.

The products subject to recall bear establishment number “EST. 6063A” printed on the retail labels next to the lot number and inside the USDA mark of inspection on the case labels. These items were shipped to retail locations in California.

FSIS was notified of an investigation of Salmonella Dublin illnesses on September 9, 2019. Working in conjunction with the Centers for Disease Control and Prevention (CDC), and state and local public health partners, FSIS determined that there is a link between ground beef products from Central Valley Meat Co., Inc., and this illness cluster. The traceback investigation indicated that a case-patient consumed ground beef produced by Central Valley Meat Co., Inc. Based on epidemiological investigation, 10 case-patients have been identified in 6 states with illness onset dates ranging from August 8, 2019 to September 22, 2019. Additional information may be found on the CDC website at https://www.cdc.gov/salmonella/dublin-11-19/index.html. This outbreak strain of Salmonella Dublin did not identify any antibiotic resistance. FSIS continues to work with the CDC and state and local public health partners on this investigation and will provide updated information as it becomes available. (more…)

Summary

Company Announcement Date:
November 13, 2019
FDA Publish Date:
November 13, 2019
Product Type:
Food & Beverages
Reason for Announcement:
Potential to contain mold
Company Name:
Vitamin Cottage Natural Food Markets, Inc.
Brand Name:
Natural Grocers
Product Description:
Organic Soybeans

Company Announcement

Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand 2-pound Organic Soybeans because they have the potential to contain mold. Consumers who may have purchased this product are advised to discontinue use and either throw it away or return it to the store for credit or refund.

The recalled product is packaged in clear plastic bags weighing 2 pounds and bearing the “Natural Grocers” label. Only packages bearing 19-168 and 19-205 as the packed-on dates are subject to recall.  The packed-on date can be found in the bottom left-hand corner of the label.

The potential for contamination was noted after routine testing by the company revealed the presence of mold.

Production of the product has been suspended while the Food and Drug Administration and the company continue their investigation into the source of the problem. (more…)

Summary

Company Announcement Date:
November 13, 2019
FDA Publish Date:
November 13, 2019
Product Type:
Animal & Veterinary
Reason for Announcement:
Excess Magnesium
Company Name:
CHS Inc.
Brand Name:
Payback®
Product Description:
Feeds for rabbit, turkey/pheasant, swine, waterfowl

Company Announcement

CHS Inc., based in Inver Grove Heights, Minnesota, is voluntarily recalling 67 tons of Payback® Feeds listed below due to potentially high levels of magnesium.

The acute effects of excess dietary magnesium in animals would likely be osmotic diarrhea and a marked decrease in feed intake. Continued feeding of these products may result in death as a complication of diarrhea and decreased feed intake. If your animals have consumed the recalled products and have these symptoms, please contact your veterinarian.

The products were manufactured at the CHS Great Falls, Montana, facility and distributed in Wyoming and Montana with dates between 9-27-2019 and 10-4-2019. The products were sold directly to producers and to dealers, where end-use customers may have purchased the products.

The products are bagged in 50 lb. Payback Feed bags that display the Payback Feed Brand. The following products, lot numbers and manufacture dates are included in this recall:

Product Name Lot Number Manufacture Date
Payback Champion Rabbit M644310 09/30/2019
Payback Egg Layer Ration Pellet M644570 09/30/2019
Payback Egg Layer Ration Krumble M644550 09/30/2019
Payback Turkey /Pheasant Grower A Medicated M650210 10/04/2019
Payback Turkey /Pheasant Grower M644560 09/30/2019
Payback Swine Complete Breeder M643210 09/27/2019
Payback Waterfowl Feed M644540 09/30/2019

CHS received reports from customers claiming these products may have resulted in illness and/or mortality potentially linked to the products. CHS has received reports of the deaths of 403 pheasants from a dealer’s customer. (more…)

Summary

Company Announcement Date:
November 13, 2019
FDA Publish Date:
November 13, 2019
Product Type:
Dietary Supplements
Drugs
Reason for Announcement:
Due to unapproved active ingredient (sildenafil)
Company Name:
Nature’s Rx
Brand Name:
Silver Bullet
Product Description:
Male Enhancement Capsules

Company Announcement

Nature’s Rx is voluntarily recalling lot: 01251ZX1, Expiry Date: 11/2022 of Silver Bullet (10 Male Enhancement Capsules). This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, the active ingredient in Viagra, which is a PDE-5 inhibitor. The undeclared PDE-5 inhibitor in the product may pose serious health risks to consumers with underlying medical issues. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

To date, Nature’s Rx has not received any reports of adverse events related to this recall. (more…)

Name of product:
Snapper Rear Engine 33” Riding Mowers
Hazard:

A faulty blade engagement lever can keep the lawnmower blade engaged after the release of the foot activated disengagement pedal, posing an injury hazard.

Remedy:
Repair
Recall date:
November 14, 2019
Units:
About 1,160
Consumer Contact:

Briggs & Stratton at 800-227-3798 from 8 a.m. to 5 p.m. CT Monday through Friday or www.briggsandstratton.com and click on “Recalls” under the Support tab for more information.

Recall Details

Description:

This recall involves Snapper Rear Engine Riding Mowers with rear engines and a 33 inch mower deck. The riding mowers are red and black. Model number 2691526, Briggs & Stratton and 33” are printed on a white label the back of the mower. SNAPPER is printed on the front of the mower.

Remedy:

Consumers should immediately stop using the recalled riding mowers and contact Briggs & Stratton for a free inspection and repair.

Incidents/Injuries:

None reported (more…)

Name of product:

Kenmore Elite Microwave Ovens

Hazard:

Incorrect wiring causes the microwave’s exterior to reach temperatures exceeding 183 degrees Fahrenheit, posing a burn hazard to the user.

Remedy:

Repair

Recall date:

November 14, 2019

Units:

About 700

Consumer Contact:

Sears at 800-659-7026 from 7 a.m. to 7 p.m. CT Monday through Friday, or online at www.sears.com and click on “Product Recalls” for more information.

Recall Details

Description:

This recall involves 1,000-watt countertop convection microwave ovens manufactured under the Kenmore Elite brand name on April 27, 2017. This manufacturing date of the recalled microwave ovens is identifiable by the first six digits of their serial numbers, each of which begins with the numerals “170427”. The model number of the recalled microwaves is “204.77603610”. The brand name, model number and serial number can be found on the data plate on the back of the (more…)

Name of product:
ALOCANE® Emergency Burn Pads
Hazard:

The packaging is not child resistant as required by the Poison Prevention Packaging Act. The pads contain lidocaine, posing a risk of poisoning to young children if they were to place the pad in their mouth.

Remedy:
Refund
Replace
Recall date:
November 14, 2019
Units:
About 153,000
Consumer Contact:

Quest Products at 800-650-0113 from 9 a.m. to 5 p.m. CT Monday through Friday, or online at www.alocane.com and click on “Contact Us” for more information.

Recall Details

Description:

This recall involves the ALOCANE® Emergency Burn Pads (10 count and 15 count) which come in a white and red box with “MAXIMUM STRENGTH ALOCANE® Emergency Burn Pads” printed on the front. The product is an over the counter Gel Infused Pad with lidocaine (4%) as the active ingredient. The pads are sold in a 10 count box and 15 count box with the lot numbers 4179, 4180, 4235, 4645, 4646 or 4698 printed next to the barcode on the box. The UPC number for the affected product is 8-46241-02448-7 and can be found on the bottom of the box.

Remedy:

Consumers should immediately stop using the recalled burn pads, store the pads in a safe location out of reach of children and contact Quest Products to return the pain relieving pads for a free ALOCANE® Emergency Burn Gel 2.5 ounce child resistant tube or a full refund.

Incidents/Injuries:

None reported (more…)

Summary

Company Announcement Date:
November 12, 2019
FDA Publish Date:
November 13, 2019
Product Type:
Food & Beverages
Soup
Reason for Announcement:
Undeclared fish and wheat
Company Name:
Kettle Cuisine
Brand Name:
Marketside
Product Description:
Marketside Brand Creamy Cauliflower Parmesan Soup

Company Announcement

Kettle Cuisine of Lynn, MA is voluntarily recalling Marketside Brand Creamy Cauliflower Parmesan Soup 16oz because a limited quantity of retail pots may contain Fish and Wheat allergens not declared on the label. People who have an allergy or severe sensitivity to Wheat and/or Fish should not consume the product as it may cause a serious or life-threatening reaction.

Product was distributed to Walmart stores in all 50 states for purchase in store or online.

Product is packed into 16oz plastic retail lidded cups, labeled as ‘Marketside Brand Creamy Cauliflower Parmesan Soup’ – UPC 8113130636 with Use-by dates ranging from 11/23/19 to 01/01/20 inclusive.

No adverse reactions or illnesses have been reported regarding this product to date. (more…)

Summary

Company Announcement Date:
November 08, 2019
FDA Publish Date:
November 12, 2019
Product Type:
Drugs
Reason for Announcement:
Due to potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA
Company Name:
Amneal Pharmaceuticals, LLC
Brand Name:
Amneal
Product Description:
Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL

Company Announcement

Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey is voluntarily recalling Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL to the consumer level. A listing of the recalled lots is identified below.

Ranitidine Tablets, USP, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.

Amneal Pharmaceuticals, LLC. has not received any reports of adverse events that have been confirmed to be directly related to this recall. Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP), manufactured by Amneal, are prescription oral products. Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease. (more…)