Tag: FDA

FDA, CDC investigating Salmonella outbreak linked to shell eggs

Raw shell eggs from Gravel Ridge Farms (Cullman County, Alabama) are being blamed for 14 cases of Salmonella Enteritidis illnesses in Tennessee and Alabama according to reports from FDA and CDC.

Illnesses started on dates ranging from July 10, 2018 to August 7, 2018; two victims were hospitalized.

Thirteen of the 14 outbreak patients reported eating restaurant dishes made with eggs. FDA and state partners traced the source of the shell eggs supplied to these restaurants to Gravel Ridge Farms.

On September 8th, Gravel Ridge Farms recalled Gravel Ridge Farms Large Cage Free Eggs (Single Dozen and 2.5 Dozen Flats; Use by 7/25/18 through 10/3/18; UPC 7-06970-38444-6), and has ceased the production and distribution of the product while FDA and the company investigate the source of the contamination.

Recalled product was 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.

The following retail stores carried the recalled eggs:

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

Consumers who have purchased these products should return them to the 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.

FDA Public Health Alert: Avoid using King Bio drugs and homeopathic products

Drugs and homeopathic products manufactured by King Bio Inc. (Asheville, NC) may contain high levels of microbial contamination and pose a risk to humans and pets.

In an alert posted today, FDA recommended that consumers stop using these products, and dispose of them immediately.

The FDA announcement coincided with a voluntary nationwide recall initiated by the manufacturer of all aqueous-based products for human and animal use. A complete list of recalled products has been posted on the company’s website.

This is the third product recall announced by King Bio since July 20, 2018.

Among the products included in the most recent recall are: Dr. King’s Children’s Cough Relief, Dr. King’s Chicken Pox Symptom Relief, Dr. King’s Children’s Ear Relief Formula, Dr. King’s Children’s Appetite Enhancer, Dr. King’s Attention and Learning Enhancement For Kids, Dr. King’s Cold Sore treatment, Dr. King’s Wart Freeze, and pet products for urinary incontinence and digestion relief.

The recall announcement and the associated consumer alert follow an inspection of the company’s manufacturing facility by FDA – an inspection that uncovered substandard conditions, including recurring microbial contamination associated with the water system used to manufacture the drug products.

FDA found several microbial contaminants during the course of its investigation, including Burkholderia Multivorans, a strain of bacteria that can cause illness in people with compromised immune systems.

What should consumers do?
The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of King Bio’s products to the FDA’s MedWatch Adverse Event Reporting program:

For reporting adverse drug events in animals, please see How to Report Animal Drug Side Effects and Product Problems.

FDA continues to review possible link between pet diets and canine heart disease

This story by Phyllis Entis first appeared in Food Safety News and is reposted here with permission

A diet rich in legumes or potatoes might be linked to an increased risk of canine dilated cardiomyopathy (DCM), according to the Food and Drug Administration.

Prior to issuing a public notice on July 12, the FDA had received sporadic reports involving 30 dogs and 7 cats over a three-year period. During that same period, the veterinary cardiology community received about 150 similar reports. In dogs, the disease results in an enlarged heart.

Some of the dogs exhibited signs of heart disease, including decreased energy, cough, difficulty breathing, and episodes of collapse. Reports received by FDA identified a range of brands and formulas. 

The common element in these foods appears to be the presence of legumes (including peas, beans, lentils, chickpeas, soybeans, peanuts), pulses (seeds of legumes), and/or potatoes as main ingredients in the pet foods. The list also encompasses protein, starch or fiber derived from legumes.

Since the July 12 notification, FDA has received additional reports, which it is in the process of evaluating. None of these reports involve cats. According to a spokesperson from FDA, the agency is not able to provide an accurate accounting at this time, as the number of reports is continuing to rise and the information is being analyzed as it is received.

Some dog breeds are genetically susceptible to developing DCM. However, at least some of the initial reports to FDA involved other breeds of dog not typically prone to this disease. FDA is evaluating various possible dietary causes of DCM in dogs, including, nutritional makeup of the main ingredients or how dogs process them, main ingredient sourcing, processing, and amount used.

At this point in its investigation, FDA is not advising dog owners to make any dietary changes. Pet owners whose dogs are showing any symptoms of DCM or other heart conditions should contact their veterinarian.

FDA is encouraging pet owners and veterinary professionals to report cases of DCM in dogs suspected of having a link to diet by using the electronic Safety Reporting Portal or calling their state’s FDA Consumer Complaint Coordinators.