Class IIITerminated · reported 2014-12-24

Product comes in as part of Fabulous Fudge Gift Box. The Gift box contains 2 samples of…

Tastefully Simple, Inc recalled this product and the FDA reported the enforcement action on 24 December 2014 as Class III. The recall was initiated by the firm. Tastefully Simple is recalling various lots of Cookie & Cream Fudge(Fabulous Fudge Gift) because the product appears to have mold growing on the small chocolate cookie pieces on the top of the Cookies & Cream Fudge.

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

Product
Product comes in as part of Fabulous Fudge Gift Box. The Gift box contains 2 samples of the recalled product, Cookies & Cream Fudge and 2 samples of a second product not being recalled. The product comes in small plastic container with lid (3.5" x 2.5" x 21.875"). A small spoon is also present in the package. Gift Box Label: Fabulous Fudge, Tastefully Simple, Cookies & Cream Fudge, Creamy Chocolate Fudge, 4 - 2.5 oz cups newt WT 10 oz (280 g), Item #421129. Individual Package Label: tastefully simple, Cookies & Cream Fudge, Net WT 2.5 oz (70 g), Item #758604.
Reason for recall
Tastefully Simple is recalling various lots of Cookie & Cream Fudge(Fabulous Fudge Gift) because the product appears to have mold growing on the small chocolate cookie pieces on the top of the Cookies & Cream Fudge.
Recalling firm
Tastefully Simple, Inc
Firm location
Alexandria, Minnesota, United States
Classification
Class III
Status
Terminated
Recall number
F-0713-2015
Quantity
4,257 gift sets and 1,638 indivdual units for a total of 10,152 units.
Distribution
Nationwide.
Initiated
18 November 2014
Reported by FDA
24 December 2014
Terminated
4 February 2015
Firm notified by
E-Mail
Product codes
Lot & (Best Buy Day): Lots: 3439 (02/09/15) , 3464 (02/09/15) , 3636 (02/09/15, 02/14/15, 02/15/15) , 3739 ( 02/14/15, 02/15/15, 04/13/15).

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

  • Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
  • The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
  • This record is the only one the FDA opened for its recall event, so it covers a single product code.
  • The recall ran for 3 months, from 18 November 2014 to termination on 4 February 2015. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
  • The FDA published the enforcement report 5 weeks after the firm began the recall.
  • Recalls of milk or a dairy product run a median of 7 months, so this one was shorter than usual for its category. Dairy recalls split between pathogen contamination in products that skipped or under-ran pasteurisation and undeclared milk in products that should never have contained it, which is the same allergen viewed from two directions.

What this recall was for

Spoilage and mould

A spoilage recall means the food degraded before its date: mould growth, unintended fermentation, swelling or rancidity, usually traced to a seal, a formulation or a storage temperature.

A preventive controls plan covers spoilage under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.

21 CFR 117.93
Warehousing and distribution: storage and transport under conditions that protect food against contamination and against deterioration of the food and its container.
21 CFR 117.80(b)(3)
Time and temperature: holding food at temperatures that do not allow microorganisms to grow, and for no longer than the process allows.

Filed under milk and dairy, bakery and snacks and confectionery. A product can sit in more than one.

Other milk and dairy recalls for the same reason

These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.

ReportedProductFirmReasonClass
2025-01-29Horizon Organic Aseptic Plain Whole Milk 8OZ 12 Pack. Refrigerate after opening. With the following UPC: 3663207113 (12 pack); 3663207127 (single unit). Distributed by: Danone US, LLC Broomfield, CO 80021. HOD (Horizon Organic Dairy) #: 140236Horizon Organic Dairy, LLCPotential for premature product spoilage during shelf life.Class II
2024-10-30Horizon Organic Ultra Pasteurized Heavy Whipping Cream, refrigerated, One Pint (473ml), UPC 7 42365 21685 5. There are 12 cartons per case. Distributed by: Horizon Organic Dairy, LLC (Horizon) Broomfield, CO 80021.UPC: 742365216855Horizon Organic Dairy, LLCPotential for premature product spoilage during shelf life.Class II
2024-09-11Item 71117.56013, Reser's Sweet Corn with Butter, refrigerated product, net wt. 4lb. There are 4 packs per case.Reser's Fine Foods, Inc.Product may become spoiled due to temperature abuse. The temperature abuse was the result of a malfunctioning refrigeration unit on trailer #184.Class II
2024-08-21Pariva Marinated Labneh Bites Rosemary Garlic; NET WT 8 OZ (225g); INGREDIENTS: YOGURT (CULTURED PASTEURIZED GRADE A MILK & CREAM, SKIM MILK, WHEY PROTEIN CONCENTRATE, SALT AND PECTIN), *SUNFLOWER OIL, *EXTRA VIRGIN OLIVE OIL, ROSEMARY SPICES; CONTAINS: MILK, Distributed by, Mayur, LLC, 196 Quincy St., Dorchester, MA 02121; KEEP REFRIGERATED; UPC 647297431201; Packaged in glass jars with metal or plastic lidsPariva LLCProduct may be contaminated with mold.Class II
2024-08-21Pariva Marinated Labneh Bites Za'atar; NET WT 8 OZ (225g); INGREDIENTS: YOGURT (CULTURED PASTEURIZED GRADE A MILK & CREAM, SKIM MILK, WHEY PROTEIN CONCENTRATE, SALT AND PECTIN), *SUNFLOWER OIL, *EXTRA VIRGIN OLIVE OIL, SESAME SEEDS, SPICES; CONTAINS: MILK, SESAME; Distributed by, Mayur, LLC, 196 Quincy St., Dorchester, MA 02121; KEEP REFRIGERATED; UPC 647297431201; Packaged in glass jars with metal or plastic lidsPariva LLCProduct may be contaminated with mold.Class II
2024-08-21Pariva Marinated Labneh Bites Mild Tandoori; NET WT 8 OZ (225g); INGREDIENTS: YOGURT (CULTURED PASTEURIZED GRADE A MILK & CREAM, SKIM MILK, WHEY PROTEIN CONCENTRATE, SALT AND PECTIN), *SUNFLOWER OIL, *EXTRA VIRGIN OLIVE OIL, SPICES; CONTAINS: MILK, Distributed by, Mayur, LLC, 196 Quincy St., Dorchester, MA 02121; KEEP REFRIGERATED; UPC 647297431201; Packaged in glass jars with metal or plastic lidsPariva LLCProduct may be contaminated with mold.Class II
2024-02-14MARBURGER 40% HEAVY CREAM 1/32OZ SUPC/ITEM # 039127PGreco SidariThe food was not held at an appropriate temperature. The holding temperature could affect spoilage and potentially support pathogen growth.Class II
2023-05-10Atkins Milk Chocolate Delight Protein Rich Shakes, NET WT. 44 oz (4 / 11oz), 4 Tetra Packs per carton, UPC 637480065016, Distributed exclusively by Simply Good Foods USA, Inc. Denver, CO 80202, 1-800-6-ATKINSSIMPLY GOOD FOODS COThis recall has been initiated because a contamination event downstream of the thermal process deemed the product not commercially sterile and creates the potential for product spoilage.Class II

Other records from Tastefully Simple, Inc

The FDA opens one enforcement record per product code, so several of these are frequently one recall event.

All 2014 recalls · All FDA food recall data

21 CFR 117.93 is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

Early access

Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.