FDA Warning Letters - Three Importers Cited for FSVP Violations

FDA issued Warning Letters to three importers on issues involving compliance to FSVP.  The FSVP regulation is in place to ensure that food entering into the US meets US food safety standards.

California Terra Garden Inc. of  Commerce CA, an importer of mushrooms, did not take compliance with the Produce Safety Rule into account when approving the supplier and did not have adequate assurance that the significant hazards were being controlled.as required by the Produce Safety Rule.  The supplier information was not translated into English

Bella Rosa Distribution Inc of Minneapolis, MN did not develop, maintain, and follow an FSVP for any of the foods you import, including the following three foods:

JD's Market Inc. of Lynnwood, WA 98036-6601 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, you did not develop, maintain, and follow an FSVP for any of the foods you import

Sichuan Chili BBQ Rub Spice Blend Recalled After Wrong Product Packaged in Jars Resulting in Undeclared Sesame

The Spice House is voluntarily recalling Sichuan Chili BBQ Rub because it may contain undeclared sesame.  The product is being recalled because the wrong spice blend may be in the bottle and therefore it could contain undeclared sesame. Less than 40 jars of the product are affected by this issue, but all Sichuan Chili BBQ Rub produced is being recalled.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/spice-house-issues-allergy-alert-undeclared-sesame-sichuan-chili-bbq-rub
The Spice House Issues Allergy Alert on Undeclared Sesame in Sichuan Chili BBQ Rub
Summary
Company Announcement Date:  November 22, 2021
FDA Publish Date:  November 22, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared sesame
Company Name:  The Spice House
Brand Name:  The Spice House
Product Description:  Sichuan Chili BBQ Rub

Powdered Beverages Recalled After Process Review Finds Potential for Foreign Material

Kraft Heinz is recalling select code dates of Country Time Lemonade, Tang, Arizona Tea powdered beverages and limited Kool- Aid powdered beverages with “Best When Used By” dates between May 10, 2023 and November 1, 2023 due to the potential presence of foreign material, specifically very small pieces of metal or glass, that may have been introduced during production.  The issue was first discovered during an internal review at the manufacturing facility. The Company is actively working with retail partners and distributors to remove potentially impacted product from circulation.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kraft-heinz-voluntarily-recalls-select-country-time-lemonade-tang-arizona-tea-powdered-beverages-and
Kraft Heinz Voluntarily Recalls Select Country Time Lemonade, Tang, Arizona Tea Powdered Beverages and Limited Kool-Aid Powdered Beverage Products in U.S. and Select Country Time Lemonade and Tang Powdered Beverages in Canada
Summary
Company Announcement Date:  November 20, 2021
FDA Publish Date:  November 22, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Potential presence of glass and metal
Company Name:  Kraft Heinz
Brand Name:  Country Time, Tang, Kool-Aid, Arizona Tea
Product Description:  Country Time Lemonade, Tang, Arizona Tea powdered beverages and Kool-Aid powdered beverage products

Hummus Recalled for Undeclared Milk Allergen

TaDah! Foods of Springfield, VA is voluntarily recalling two batches of production of Spicy Brown Sugar Harissa Hummus due to an undeclared milk allergen. There have been no reported illnesses.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tadah-foods-springfield-va-voluntarily-recalling-two-batches-production-spicy-brown-sugar-harissa
TaDah! Foods of Springfield, VA is Voluntarily Recalling Two Batches of Production of Spicy Brown Sugar Harissa Hummus Due to an Undeclared Milk Allergen
Summary
Company Announcement Date:  November 17, 2021
FDA Publish Date:  November 22, 2021
Product Type:  Food & Beverages Organic Food / Home Grown  
Reason for Announcement:  Undeclared milk allergen
Company Name:  Tadah! Foods
Brand Name:  TaDah!
Product Description:  Spicy Brown Sugar Harissa Hummus

Chocolate Covered Malted Milk Balls Recalled After Employee Finds a Chocolate Covered Peanut in Package

Cargill is voluntarily recalling 469, one-pound bags of Wilbur Dark Chocolate Triple Covered Malted Milk Balls. Sold locally through the Wilbur Chocolate Store in Lititz, Pa. and online at Wilburbuds.com, the bags are being recalled because it may contain undeclared peanut allergen.  While packaging the Wilbur Dark Chocolate Triple Covered Malted Milk Balls, a Cargill employee identified a milk-chocolate covered peanut within the malted milk balls and packaging production was immediately stopped. The bag labels do bear a “may contain peanut” statement; however, we are recalling the product in an abundance of caution.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cargill-voluntarily-recalls-469-one-pound-bags-wilbur-dark-chocolate-triple-covered-malted-milk
Cargill voluntarily recalls 469, one-pound bags of Wilbur Dark Chocolate Triple Covered Malted Milk Balls due to possible peanut allergen presence
Summary
Company Announcement Date:  November 19, 2021
FDA Publish Date:  November 19, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared peanuts
Company Name:  Cargill
Brand Name:  Wilbur
Product Description:   Dark Chocolate Triple Covered Malted Milk Balls

Sliced Picked Beets in Jars Recalled for Possible Acidification Issue

Seneca Foods is recalling its Aunt Nellies Sliced Pickled Beets in Glass Jars, 160z due to potential issues with high pH due to lack of acidification.  "Possible elevated pH levels due to lack of acidulant that may allow for microbial growth. Seneca Foods has received reports of a lack of pickled flavor in 16oz glass jars of sliced pickled beets. Through our investigation, it has been determined that a potential for insufficient acidulant is possible during a specific time frame from the 21st of July, 2021 production. The scope of this issue was very limited in nature, and involved only a limited amount of production. Out of an abundance of caution, Seneca Foods is recalling product at the retail level that is associated with this event from 14:15 through 19:50. No complaints of spoilage or illness have been reported."

https://www.heinens.com/product-recalls/

FDA Provides Update on Salmonella Outbreak Associated with Onions from Mexico, Additional Recalls Issued

FDA released an update on the ongoing Salmonella outbreak associated with onions imported from Mexico.  There are now 892 cases with 183 hospitalizations.  This outbreak was first announced in October of this year.  There were additional recall updates published by FDA this week.

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-oranienburg-whole-fresh-onions-october-2021

Outbreak Investigation of Salmonella Oranienburg: Whole, Fresh Onions (October 2021)
Do not eat, sell, or serve recalled onions from ProSource Produce LLC and Keeler Family Farms

The FDA, along with CDC and state and local partners, is investigating a multistate outbreak of Salmonella Oranienburg infections linked to whole, fresh onions. FDA’s traceback investigation is ongoing but has identified ProSource Produce, LLC (also known as ProSource Inc.) of Hailey, Idaho, and Keeler Family Farms of Deming, New Mexico, as suppliers of potentially contaminated whole, fresh onions imported from the State of Chihuahua, Mexico.

As of November 12, 2021, CDC reports that there are 892 illnesses in 38 states and Puerto Rico.

Curry Powder Recalled After NY State Testing Finds Peanut Allergen

Spice N’ More Corp. of Brooklyn, NY, is recalling its 13 ounce (368 grams) containers of “Salma Natural Curry Powder” with Lot # H092021 and best by date 12/20/23 because they may contain undeclared peanuts.  The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed that the peanut-containing product was distributed in containers that did not reveal the presence of peanuts.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/spice-n-more-corp-issues-allergy-alert-undeclared-peanuts-salma-natural-curry-powder-lot-h092021
Spice ‘N’ More Corp. Issues Allergy Alert on Undeclared Peanuts in Salma Natural Curry Powder (Lot # H092021)
Summary
Company Announcement Date:  November 16, 2021
FDA Publish Date:  November 16, 2021
Product Type:  Food & Beverages  Spices, Flavors & Salts
Reason for Announcement:  Undeclared peanuts
Company Name:  Spice N’ More Corp.
Brand Name:  Salma
Product Description:  Curry powder

FDA Warning Letter - Two Animal Feed Companies With High Levels of Medication

FDA issued two warning levels to two animal feed companies.  Both companies had shipped cattle feed with higher levels of monensin, a medication used in animal feeds.   In both cases, poor practices led to higher levels than was indicated on the label.

Bartlett Cooperative Association Bartlett Feed Mill of Bartlett, Kansas - inspection was conducted after a voluntary recall of a custom formulated cattle feed that was reported to have contributed to the death of approximately eighty-seven (87) cattle upon its consumption.

• The inspection revealed evidence of a significant violation of the Current Good Manufacturing Practice (CGMP) regulations for non-licensed medicated animal feed manufacturers, Title 21, Code of Federal Regulations, Part 225 (21 CFR Part 225). Failure to follow these requirements causes medicated feeds and non-medicated animal foods manufactured at your facility to be adulterated 
• The inspection revealed evidence that you manufactured and distributed a cattle feed that contained a super-potent concentration of the new animal drug monensin. This Type C medicated cattle feed containing the Type A medicated article of monensin is unsafe within the meaning of Section 512(a)(2)(A) of the FD&C Act [21 U.S.C. § 360b(a)(2)(A)] because it was not in conformance with the animal drug approval. As a result, the animal feed containing the new animal drug is adulterated under Section 501(a)(6) of the FD&C Act [21 U.S.C. § 351(a)(6)].
• The inspection found evidence that this custom cattle feed is also misbranded within the meaning of Section 502(a)(1) of the FD&C Act [21 U.S.C. § 352(a)(1)] because it contained monensin at a concentration above the level stated in the product labeling (feeding directions accompanying the feed), making the labeling false or misleading.

Lewiston Feed & Produce Company
Lewiston Feed and Produce Company of, Lewiston, Minnesota, was inspected in response regarding elevated levels of monensin in the customer-formula medicated feed “(b)(4),” batch code 619202. Our inspection found that you adulterated this medicated animal feed in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

• based on the level of monensin in the medicated feed  manufactured, the company actually manufactured a Type B medicated feed, rather than a Type C feed. Monensin is approved for use in Type B medicated animal feed at 41 to 80,000 grams per ton2 for the intended indications. A Type B medicated feed is intended for further manufacture, 21 CFR 558.3(b)(3). The label of your medicated feed did not include any mixing instructions. Failure to label a medicated animal feed with adequate directions for use results in that product being misbranded.2