Massive Muscle Gainer- Weight Gainer¿ Dutch Chocolate¿10 LBS: Whey Protein/Isolate, Soy…
Chemi- Source Inc, Nutra Pak recalled this product and the FDA reported the enforcement action on 12 June 2013 as Class II. The recall was initiated by the firm. Source of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
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
- Massive Muscle Gainer- Weight Gainer¿ Dutch Chocolate¿10 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate, Cocoa UPC 6-09492 73002-2
- UPC
- 609492730022
- Reason for recall
- Source of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
- Recalling firm
- Chemi- Source Inc, Nutra Pak
- Firm location
- Grand Rapids, Michigan, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1494-2013
- Quantity
- 14,813
- Distribution
- nationwide
- Initiated
- 2 April 2013
- Reported by FDA
- 12 June 2013
- Terminated
- 15 April 2014
- Firm notified by
- Telephone
- Product codes
- expiration date between Jan 2013 and March 2016.
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 26 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 26 separate recalls, which almost every published figure does, overstates it by a factor of 26. 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 26 of them.
- The recall ran for 12 months, from 2 April 2013 to termination on 15 April 2014. 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 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.
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 and beverages and juice. 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 Chemi- Source Inc, Nutra Pak
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 25 other records name this firm.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2013-06-12 | All Natural Whey - Natural Flavor 1.89 LBS: Whey Protein Concentrate and Isolate, Casein/Caseinate, Nitrozyme UPC 6-09492 72000-9 : | Chemi- Source Inc, Nutra Pak | Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. | Class II |
| 2013-06-12 | Casein - 100% Micellar Casein - Rich Chocolate¿2.02 LBS: Soy Lecithin,Casein/Caseinate, Cocoa UPC 6-09492 72240-9 | Chemi- Source Inc, Nutra Pak | Source of casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. | Class II |
| 2013-06-12 | Fruit-N-Whey 2.03lbs and Fruit-N-Whey Mixed Berries 2.03 lbs: Whey Protein/Isolate, Soy Lecithin. Contains: Dairy, Benefruit Blend, Natural Berry Flavors UPC 6-09492 72065-8 | Chemi- Source Inc, Nutra Pak | Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. | Class II |
| 2013-06-12 | Low Carb Protein¿ -¿ Creamy Chocolate¿1.78 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate, Cocoa UPC 6-09492 72017-7 | Chemi- Source Inc, Nutra Pak | Source of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. | Class II |
| 2013-06-12 | Isolate Whey Protein French Vanilla 1.99 LBS: Whey Protein Concentrate/ Isolate, Casein/Caseinate, Contains: Soy, Dairy, Xylitol UPC 6-09492 73011-4 | Chemi- Source Inc, Nutra Pak | Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. | Class II |
| 2013-06-12 | Sprouts Farmers Market Whey Protein Chocolate: 1 lbs, 2 lbs : Whey Protein/Isolate, Soy Lecithin UPC 6-46670 68120-2 (1 lbs) UPC 6-46670 68126-4 (2 lbs) | Chemi- Source Inc, Nutra Pak | Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. | Class II |
| 2013-06-12 | Massive Muscle Gainer- Weight Gainer¿ French Vanilla¿10 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate UPC 6-09492 73003-9 | Chemi- Source Inc, Nutra Pak | Source of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. | Class II |
| 2013-06-12 | Casein - 100% Micellar Casein - Vanilla Ice Cream¿2.04 LBS: Soy Lecithin,Casein/Caseinate UPC 6-09492 72241-6 | Chemi- Source Inc, Nutra Pak | Source of casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. | Class II |
| 2013-06-12 | Metabolic Whey - Vanilla¿5 LBS French Vanilla 10lbs: Whey Protein/Isolate, Soy Lecithin UPC 6-09492 72051-1 (VANILLA) UPC 6-09492 72054-2 (FRENCH VANILLA) | Chemi- Source Inc, Nutra Pak | Source of whey ingredient not listed as milk, an allergen; soy lecithin stated as "lecithin".Consumers who have an allergy or severe sensitivity to milk or soy run the risk of a serious or life-threatening allergic reaction if they consume these products. | Class II |
| 2013-06-12 | All Natural Gainer- Rich Vanilla¿3.3 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate UPC 6-09492 73003-9 | Chemi- Source Inc, Nutra Pak | Source of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. | Class II |
All 26 records for Chemi- Source Inc, Nutra Pak
All 2013 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.