Atkins Dark Chocolate Royale Protein Rich Shakes, NET WT. 44 oz (4 / 11oz) 4 Tetra packs…
SIMPLY GOOD FOODS CO recalled this product and the FDA reported the enforcement action on 10 May 2023 as Class II. The recall was initiated by the firm. This 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.
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
- Atkins Dark Chocolate Royale Protein Rich Shakes, NET WT. 44 oz (4 / 11oz) 4 Tetra packs per carton, UPC 637480065108, Distributed exclusively by Simply Good Foods USA, Inc. 1 Denver, CO 80202 1-800-6-ATKINS.
- UPC
- 637480065108
- Reason for recall
- This 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.
- Recalling firm
- SIMPLY GOOD FOODS CO
- Firm location
- Denver, Colorado, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0809-2023
- Quantity
- 485 Cases (total 1940 units)
- Distribution
- Nationwide
- Initiated
- 30 March 2023
- Reported by FDA
- 10 May 2023
- Terminated
- 4 August 2023
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Lot# SA2297P3F6 Expiration date: 10/24/23 Lot# SA2298P3F6 Expiration date: 10/25/23 Lot# SA2299P3F6 Expiration date: 10/26/23
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 2 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 2 separate recalls, which almost every published figure does, overstates it by a factor of 2. 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 2 of them.
- The recall ran for 4 months, from 30 March 2023 to termination on 4 August 2023. 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 6 weeks after the firm began the recall.
- Recalls of a snack or confectionery product run a median of 7 months, so this one was shorter 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.
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.
Process deviation
A process deviation recall means the process ran outside its validated limits: a thermal process that did not reach its time and temperature, a pH that drifted, or a seal that failed.
A preventive controls plan covers a process deviation 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 113
- Thermally processed low-acid foods in hermetically sealed containers: the scheduled process, its establishment by a competent authority, and the records proving every container received it.
- 21 CFR 114
- Acidified foods: the controls on equilibrium pH at or below 4.6, and the process that achieves it.
- 21 CFR 117.150
- Corrective actions: what a facility does when a preventive control was not properly implemented, including identifying and correcting the problem and evaluating the food for safety.
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 SIMPLY GOOD FOODS CO
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2023-05-10 | Atkins 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-ATKINS | SIMPLY GOOD FOODS CO | This 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 |
All 2023 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 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.