Great Shake Fortified Nutrition, Soy Formula, Strawberry Artificially Flavored, Packaged…
Hormel Foods Corporation recalled this product and the FDA reported the enforcement action on 15 March 2017 as Class II. The recall was initiated by the firm. Hormel Foods is recalling Great Shake and Great Shake Plus, fortified Nutrition drinks, due to presence of undeclared milk.
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
Great Shake Fortified Nutrition, Soy Formula, Strawberry Artificially Flavored, Packaged in 4 fl oz. (118 mL), and 6 fl oz. (177 mL). Store Frozen.
Reason for recall
Hormel Foods is recalling Great Shake and Great Shake Plus, fortified Nutrition drinks, due to presence of undeclared milk.
US: AL, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, MD, MI, MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TX, VA, WA, WV, WY, WI. OUS: Canada
Initiated
22 February 2017
Reported by FDA
15 March 2017
Terminated
23 August 2018
Firm notified by
Letter
Product codes
USE BY dates are FEB 17 17 to MAY 16 18
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 6 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 6 separate recalls, which almost every published figure does, overstates it by a factor of 6. All 6 of them are listed on this page.
The recall ran for 18 months, from 22 February 2017 to termination on 23 August 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 distribution pattern names 33 states, and the FDA published the enforcement report 3 weeks after the firm began the recall.
Recalls of fresh produce run a median of 7 months, so this one was longer than usual for its category. Fresh produce is the category where contamination arrives before the facility does: irrigation water, soil amendments and field workers are the routes, and nothing downstream of the farm is a kill step for a product eaten raw.
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.
Filed under fresh produce. A product can sit in more than one.
Every product in this recall
The FDA opened 6 enforcement records for this one recall, one per product code. This page carries all of them; the 5 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.
Hormel Foods is recalling Great Shake and Great Shake Plus, fortified Nutrition drinks, due to presence of undeclared milk.
Class II
Other fresh produce 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.
Undeclared Soy. Finished product ingredients statement declares Worcestershire sauce but does not declare sub-ingredients Soy Flavoring and Soy Lecithin.
Undeclared Soy. The firm received complaints of sausage in the burritos. Upon review the firm discovered the sausage contains soy which is not listed on the label.
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.
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.
