FDA Issues Warning Letter After Recall Due to Undeclared Allergen Due to Mislabeling Error

FDA issued a Warning Letter to Cedar’s Mediterranean Foods Inc. after a October 2021 recall where the company's Organic Mediterranean Hommus was labeled with the ingredient declaration for its Organic Everything Hommus in that the finished product label did not declare a major food allergen--tree nuts (i.e., Pine Nut).

The company provided FDA the reason for mistake - "stated that the root cause of the problem was that an employee failed to follow the label change over procedure and performed an unauthorized label change. The email also stated that you retrained all employees that perform labeling, took disciplinary action against the employee that performed the unauthorized change, and that you will develop a label reconciliation program."   In response FDA stated "it appears that you did not implement adequate allergen preventive controls."

The responsibility should not be on one employee, but a Preventive Control that incorporates monitoring and verification by additional employees.

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cedars-mediterranean-foods-inc-623473-02112022
Cedar’s Mediterranean Foods Inc.
MARCS-CMS 623473 — FEBRUARY 11, 2022

First Possible Case of COVID-19 Transmission from Deer to Human

Researchers may have identified one of the first cases of transmission of COVID-19 from white tailed deer to a person.  We have known that white tailed deer can carry the COVID-19 virus.   (Plus they are notorious non-maskers.)   A specific strain of COVID that was common among the deer crowd popped up in a human.  And that human was said to be associating with the white tail deer.  (We do not now the extent of this association, but one could guess that the human probably entered into this 'association' unmasked.

Researchers to not want to get anyone alarmed.  No reason for having to wear a mask while hiking in the woods or forcing the deer into wearing a mask through passing mandated mask-for-deer legislation.

Live Science
https://www.livescience.com/deer-to-human-covid-19-transmission
1st possible case of deer-to-human COVID-19 transmission reported
By Rachael Rettner 3/1/22
So far, it seems to be an isolated COVID-19 case.

More Dried Plums Recalled

Alli & Rose LLC is recalling dried plums due to the potential presence of lead.  The product was sold at Costco Wholesale in four states: Alaska, California, Oregon and Washington.

Dried Plums Recall Information
Summary
Company Announcement Date:  February 15, 2022
FDA Publish Date:  February 24, 2022
Product Type:  Food & Beverages
Reason for Announcement:  potential to be contaminated with lead
Company Name:  Alli and Rose LLC
Brand Name:  Snak Yard
Product Description:  Dried Plums/ saladitos

Imported Apple Pulp Recalled After Linked to Salmonella Cases

Vadilal Industries (USA) Inc. of Newark, NJ is voluntarily recalling two batches of frozen Custard Apple Pulp because it has the potential to be contaminated with Salmonella.  The recall was initiated after FDA received a single complaint reporting 5 illnesses and FDA sampling revealed the presence of Salmonella in the product.  The product is imported from India.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vadilal-industries-usa-recalls-custard-apple-pulp-because-possible-health-risk
Vadilal Industries (USA) Recalls "Custard Apple Pulp" Because of Possible Health Risk
Summary
Company Announcement Date:  February 22, 2022
FDA Publish Date:  February 22, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Salmonella
Company Name:  Vadilal Industries Inc.
Brand Name:  Vadilal
Product Description:  frozen custard apple pulp

NJ Importer Issued Warning Letter for Not Having FSVP

FDA issued a Warning Letter to Patidar Trade, Inc. of North Brunswick, NJ because they were in violoation fo teh Foreign Supplier Verification Program Regulation (FSVP) which requires companies to conduct a hazard analysis and enact verification procedures for items that are imported.  The comany did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, the company did not develop, maintain, and follow an FSVP for any of the imported foods including each of the following food products:

Wheat flour imported from (b)(4)

Rice flour imported from (b)(4)

Phool makhana imported from (b)(4)

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/patidar-trade-inc-619282-01062022
Patidar Trade, Inc.
MARCS-CMS 619282 — JANUARY 06, 2022

Inaccurate Web Posting on Recalls - Creating Confusion and Increasing Apathy

This past week, a number of outlets posted news stories stating that Giant Eagle was recalling frozen green peppers due to Listeria. The problem is, the recall occurred months ago.  These news geniuses posted it as it was current.   And then criticized the company for not having the recall on their website, and the FDA as well.

The first sighting was the lawyer-sponsored websites:

• https://www.foodsafetynews.com/2022/02/giant-eagle-recalls-frozen-bags-of-diced-green-peppers-after-testing-finds-listeria/
• https://foodpoisoningbulletin.com/2022/giant-eagle-diced-green-peppers-recalled-for-possible-listeria/

And other web-based news outlets such as MSN

• https://www.msn.com/en-us/foodanddrink/foodnews/urgent-frozen-food-recall-check-your-freezer-for-these-contaminated-veggies/ar-AAU5Ywe?ocid=uxbndlbing

All one would have to have done was to read the notice, or call the company.

Enforcement Report (fda.gov)

Event Details

Event ID:  89147

Voluntary / Mandated:  Voluntary: Firm initiated

Product Type:  Food

Initial Firm Notification of Consignee or Public:  

All products were distributed to only Giant Supermarket's in the following States: MD, PA, WV, OH and IN

Recalling Firm: 

Giant Eagle, Inc.

101 Kappa Dr

Pittsburgh, PA 15238-2809

United States

Recall Initiation Date:  11/29/2021

So now the store has to handle calls from confused consumers.  Over the long haul, people will play less attention if the information being provided is shoddy. 

The problem is that too many do not go back to the original source.  Because a lawyer-sponsored website posts something, that does not make it fact.  Rarely if ever, do they post their references.  In the end, reporters need to research this better before posting.

FDA Investigators Issue Warning for Product Out of Family Dollar's Rat-Infested Distribution Center

The FDA issued a warning for products sold at over 400 Family Dollar Stores after an FDA investigation found that the retail chain's distribution warehouse was heavily infected with rats...thousands of rats.

"The U.S. Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. 1, 2021, through the present from Family Dollar stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee may be unsafe for consumers to use. The impacted products originated from the company’s distribution facility in West Memphis, Arkansas, where an FDA inspection found insanitary conditions, including a rodent infestation, that could cause many of the products to become contaminated."

"Following a consumer complaint, the FDA began an investigation of the Family Dollar distribution facility in West Memphis, Arkansas, in January 2022. Family Dollar ceased distribution of products within days of the FDA inspection team’s arrival on-site and the inspection concluded on Feb. 11. Conditions observed during the inspection included live rodents, dead rodents in various states of decay, rodent feces and urine, evidence of gnawing, nesting and rodent odors throughout the facility, dead birds and bird droppings, and products stored in conditions that did not protect against contamination. More than 1,100 dead rodents were recovered from the facility following a fumigation at the facility in January 2022. Additionally, a review of the company’s internal records also indicated the collection of more than 2,300 rodents between Mar. 29 and Sep. 17, 2021, demonstrating a history of infestation."

"Family Dollar, Inc. is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and shipped to 404 stores from Family Dollar Distribution Center 202 in West Memphis, Arkansas from January 1, 2021 through the present due to the presence of rodents and rodent activity at Family Dollar Distribution Center 202."

https://www.fda.gov/news-events/press-announcements/fda-alerts-public-potentially-contaminated-products-family-dollar-stores-six-states

FDA Alerts the Public to Potentially Contaminated Products from Family Dollar Stores in Six States

 For Immediate Release:

February 18, 2022

FDA Issues Health Alert Regarding Infant Formula Linked to Cronobacter and Salmonella Illnesses, Michigan Facility Issues Recall

FDA issued a health warning for infant formula made at Abbott's Michigan facility after that product was linked to complaints of four infant illnesses from three states. "The FDA, along with CDC and state and local partners are investigating four consumer complaints of infant illness related to products from Abbott Nutrition’s Sturgis, MI facility received from 9/20/2021 to 1/11/2022. All of the cases are reported to have consumed powdered infant formula (IF) produced from Abbott Nutrition’s Sturgis, MI facility. These complaints include three reports of Cronobacter sakazakii infections and one report of Salmonella Newport infection in infants. All four cases related to these complaints were hospitalized and Cronobacter may have contributed to a death in one case."

From the CDC..."Cronobacter multi-species complex (formerly Enterobacter sakazakii) is a group of gram-negative bacteria that exists in the environment and which can survive in very dry conditions. The natural habitat for Cronobacter is not known. It has been found in a variety of dry foods, including powdered infant formula, skimmed milk powder, herbal teas, and starches. It has also been found in wastewater. Cronobacter illnesses are rare [2 to 4 cases per year], but they are frequently lethal for infants and can be serious among people with immunocompromising conditions and the elderly."

Cronobacter can cause diarrhea and urinary tract infections in people of all ages, but infection can be very serious in infants (<12 months), especially during the first few weeks after birth. Although cases are rare, the organism can cause a dangerous blood infection (sepsis) or make the linings surrounding the brain and spinal cord swell (meningitis).

"Cronobacter infections have been associated with consumption of reconstituted powdered infant formula. In several outbreak investigations, Cronobacter has been found in powdered infant formula that had been contaminated in the factory. In other cases, Cronobacter might have contaminated the powdered infant formula after it was opened at home or elsewhere. Powdered infant formula is not sterile. Manufacturers report that, using current methods, it is not possible to produce sterile powdered infant formula. At the factory, Cronobacter could get into formula powder if contaminated raw materials are used to make the formula, or if the formula powder touches a contaminated surface in the manufacturing environment."

https://www.fda.gov/food/outbreaks-foodborne-illness/fda-investigation-cronobacter-and-salmonella-complaints-powdered-infant-formula-february-2022
FDA Investigation of Cronobacter and Salmonella Complaints: Powdered Infant Formula (February 2022)
Do not use recalled Similac, Alimentum, or EleCare powdered infant formula
02/18/2022

Arizona Company Recalls Yogurt Raisons After Packaging Equipment Potentially Contaminated with Peanut Allergen

Lehi Valley Trading Company of Mesa, Arizona is issuing a nationwide recall of 8,10 and 12.3 oz packages of Yogurt Raisins, because it may contain undeclared Peanut Allergen.  The recall was initiated after it was discovered that equipment used to package this product may have come in contact with product containing Peanut Allergens.

One may guess that this is a situation where the packaging had run peanut-containing product and then without proper cleaning, packaged the non-peanut yogurt raison product.   Clearly an Allegan Preventive Control was not properly implemented at this step. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lehi-valley-trading-company-issues-allergy-alert-undeclared-peanut-allergen-yogurt-raisins
Lehi Valley Trading Company Issues Allergy Alert on Undeclared Peanut Allergen in Yogurt Raisins
Summary
Company Announcement Date:  February 17, 2022
FDA Publish Date:  February 17, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared peanuts
Company Name:  Lehi Valley Trading Company
Brand Name:  Snack Worthy, Woody’s Smokehouse, Texas Best Smokehouse
Product Description:  Yogurt Raisins