Class IITerminated · reported 2017-08-30

Oatmeal, Oatmeal Raisin Cookie And Caramel Sea Salt, Ice Cream Sammich, packaged in 5 oz…

Shatto Milk Co recalled this product and the FDA reported the enforcement action on 30 August 2017 as Class II. The recall was initiated by the firm. Undeclared allergens: Butter fails to disclose the presence of milk and ice cream sandwiches fail to disclose the presence of wheat.

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
Oatmeal, Oatmeal Raisin Cookie And Caramel Sea Salt, Ice Cream Sammich, packaged in 5 oz plastic bags. Shatto Milk Company, Osborn, MO.
Reason for recall
Undeclared allergens: Butter fails to disclose the presence of milk and ice cream sandwiches fail to disclose the presence of wheat.
Recalling firm
Shatto Milk Co
Firm location
Osborn, Missouri, United States
Classification
Class II
Status
Terminated
Recall number
F-3401-2017
Quantity
126 bags
Distribution
Product was distributed to retail stores in the Kansas City metro area.
Initiated
26 June 2017
Reported by FDA
30 August 2017
Terminated
17 September 2018
Firm notified by
Visit
Product codes
All best by dates prior to November 2017

Reading this record

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

  • Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. 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 is one of 8 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 8 separate recalls, which almost every published figure does, overstates it by a factor of 8. All 8 of them are listed on this page.
  • The recall ran for 15 months, from 26 June 2017 to termination on 17 September 2018. 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 2 months after the firm began the recall.
  • Recalls of ice cream or frozen dessert run a median of 7 months, so this one was longer than usual for its category. Ice cream and frozen desserts are ready to eat and never cooked again, and freezing preserves Listeria rather than killing it, which is why a positive environmental sample in a frozen dessert plant becomes a recall rather than a corrective action.

What this recall was for

Undeclared allergens

An undeclared allergen recall means a food contained one of the major allergens and the label did not say so, either because the wrong label was applied or because an ingredient carried an allergen nobody traced.

A preventive controls plan covers an undeclared allergen 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 117.135(c)(2)
Food allergen controls: the written preventive controls that keep an allergen out of a food it does not belong in, and that get the allergens present onto the label.
21 CFR 101.4
Ingredient declaration: every ingredient listed by its common name, in descending order of predominance, on the label of a packaged food.
21 CFR 117 subpart G
Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.

The allergens named in this record: milk, wheat.

Filed under ice cream and frozen desserts, milk and dairy, bakery, snacks and confectionery, spices and seasonings and grains, flour and pasta. A product can sit in more than one.

Every product in this recall

The FDA opened 8 enforcement records for this one recall, one per product code. This page carries all of them; the 7 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.

The other 7 records of FDA event 76635
ReportedProductFirmReasonClass
2017-08-30Cookin' Unsalted Butter, packaged in 8 oz plastic tubs. Plant # 29-685 Osborn, MO.Shatto Milk CoUndeclared allergens: Butter fails to disclose the presence of milk and ice cream sandwiches fail to disclose the presence of wheat.Class II
2017-08-30Brownie, Chocolate Brownie and Vanilla, Ice Cream Sammich, packaged in 5 oz plastic bags. Shatto Milk Company, Osborn, MO.Shatto Milk CoUndeclared allergens: Butter fails to disclose the presence of milk and ice cream sandwiches fail to disclose the presence of wheat.Class II
2017-08-30Plain Ol' Butter, packaged in 8 oz plastic tubs. Plant # 29-685 Osborn, MO.Shatto Milk CoUndeclared allergens: Butter fails to disclose the presence of milk and ice cream sandwiches fail to disclose the presence of wheat.Class II
2017-08-30Sugary, Sugar Cookie And Strawberry Ice Cream Sammich, packaged in 4 oz plastic bags. Shatto Milk Company, Osborn, MO.Shatto Milk CoUndeclared allergens: Butter fails to disclose the presence of milk and ice cream sandwiches fail to disclose the presence of wheat.Class II
2017-08-30Buzzzz Honey Butter, packaged in 8 oz plastic tubs. Plant # 29-685 Osborn, MO.Shatto Milk CoUndeclared allergens: Butter fails to disclose the presence of milk and ice cream sandwiches fail to disclose the presence of wheat.Class II
2017-08-30Choc + Chip, Chocolate Chip Cookie and Vanilla Ice Cream Sammich, packaged in 4.5 oz plastic bags. Shatto Milk Company, Osborn, MO.Shatto Milk CoUndeclared allergens: Butter fails to disclose the presence of milk and ice cream sandwiches fail to disclose the presence of wheat.Class II
2017-08-30Aromatic Garlic Butter, packaged in 8 oz plastic tubs. Plant # 29-685 Osborn, MO.Shatto Milk CoUndeclared allergens: Butter fails to disclose the presence of milk and ice cream sandwiches fail to disclose the presence of wheat.Class II

Other ice cream and frozen desserts 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.

Other records from Shatto Milk Co

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 9 other records name this firm.

ReportedProductFirmReasonClass
2020-10-07Shatto Milk Company, Brownie, Chocolate Brownie and Vanilla Ice Cream Sammich, Net Wt. 5 oz, Shatto Milk Company, Osborn, MOShatto Milk CoThe firm was informed by their supplier than an ingredient in the cookie portion of their ice cream sandwiches contain the undeclared major food allergen soy (soy lecithin)Class II
2020-10-07Shatto Milk Company, Choc + Chip, Chocolate Chip Cookie and Vanilla Ice Cream Sammich, Net Wt. 4.5 oz, Shatto Milk Company, Osborn, MOShatto Milk CoThe firm was informed by their supplier than an ingredient in the cookie portion of their ice cream sandwiches contain the undeclared major food allergen soy (soy lecithin)Class II
2017-08-30Cookin' Unsalted Butter, packaged in 8 oz plastic tubs. Plant # 29-685 Osborn, MO.Shatto Milk CoUndeclared allergens: Butter fails to disclose the presence of milk and ice cream sandwiches fail to disclose the presence of wheat.Class II
2017-08-30Brownie, Chocolate Brownie and Vanilla, Ice Cream Sammich, packaged in 5 oz plastic bags. Shatto Milk Company, Osborn, MO.Shatto Milk CoUndeclared allergens: Butter fails to disclose the presence of milk and ice cream sandwiches fail to disclose the presence of wheat.Class II
2017-08-30Plain Ol' Butter, packaged in 8 oz plastic tubs. Plant # 29-685 Osborn, MO.Shatto Milk CoUndeclared allergens: Butter fails to disclose the presence of milk and ice cream sandwiches fail to disclose the presence of wheat.Class II
2017-08-30Sugary, Sugar Cookie And Strawberry Ice Cream Sammich, packaged in 4 oz plastic bags. Shatto Milk Company, Osborn, MO.Shatto Milk CoUndeclared allergens: Butter fails to disclose the presence of milk and ice cream sandwiches fail to disclose the presence of wheat.Class II
2017-08-30Buzzzz Honey Butter, packaged in 8 oz plastic tubs. Plant # 29-685 Osborn, MO.Shatto Milk CoUndeclared allergens: Butter fails to disclose the presence of milk and ice cream sandwiches fail to disclose the presence of wheat.Class II
2017-08-30Choc + Chip, Chocolate Chip Cookie and Vanilla Ice Cream Sammich, packaged in 4.5 oz plastic bags. Shatto Milk Company, Osborn, MO.Shatto Milk CoUndeclared allergens: Butter fails to disclose the presence of milk and ice cream sandwiches fail to disclose the presence of wheat.Class II
2017-08-30Aromatic Garlic Butter, packaged in 8 oz plastic tubs. Plant # 29-685 Osborn, MO.Shatto Milk CoUndeclared allergens: Butter fails to disclose the presence of milk and ice cream sandwiches fail to disclose the presence of wheat.Class II

All 10 records for Shatto Milk Co

All 2017 recalls · All FDA food recall data

21 CFR 117.135(c)(2) 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.