Great Shake Fortified Nutrition, Soy Formula, Chocolate 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, Chocolate 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.
- Recalling firm
- Hormel Foods Corporation
- Firm location
- Austin, Minnesota, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1568-2017
- Quantity
- 25,774 cases for all products
- Distribution
- 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. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 6 of them.
- 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 a snack or confectionery product run a median of 7 months, so this one was longer than usual for its category. Snacks and confectionery recall for allergens more than for anything else, because a chocolate or a coated snack passes through shared equipment carrying milk, soy and nuts, and the label is the only control between them and the consumer.
Named in the distribution pattern: California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington, West Virginia, Wyoming. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
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.
Filed under snacks and confectionery. A product can sit in more than one.
Other snacks and confectionery 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 Hormel Foods Corporation
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 9 other records name this firm.
All 10 records for Hormel Foods Corporation
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 accessRecall 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.