Innate Response Gluten and Dairy Ultra Shield Enzymes 60ct. (40127)
FoodState (Nutrient Manufacturing) recalled this product and the FDA reported the enforcement action on 1 January 2014 as Class II. The recall was initiated by the firm. Potential for Chloramphenicol contamination.
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
- Innate Response Gluten and Dairy Ultra Shield Enzymes 60ct. (40127)
- Reason for recall
- Potential for Chloramphenicol contamination.
- Recalling firm
- FoodState (Nutrient Manufacturing)
- Firm location
- Londonderry, New Hampshire, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1136-2014
- Quantity
- 3,105
- Distribution
- Nationwide Foreign:
- Initiated
- 12 November 2013
- Reported by FDA
- 1 January 2014
- Terminated
- 30 June 2014
- Firm notified by
- Telephone
- Product codes
- Lot Numbers: 10517 10518 11186 11429 12107 12087
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 8 months, from 12 November 2013 to termination on 30 June 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 7 weeks after the firm began the recall.
- Recalls of milk or a dairy product run a median of 7 months, so this one was about typical for its category. Dairy recalls split between pathogen contamination in products that skipped or under-ran pasteurisation and undeclared milk in products that should never have contained it, which is the same allergen viewed from two directions.
Filed under milk and dairy. A product can sit in more than one.
Other milk and dairy recalls
These are the closest records in the corpus: the same kind of food. 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 FoodState (Nutrient Manufacturing)
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 5 other records name this firm.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2014-01-01 | Innate Response Digestive Enzymes Clinical Strength 90ct. (40126) and " Innate Response Digestive Enzymes Clinical Strength 10 Ct. Sample (90037) | FoodState (Nutrient Manufacturing) | Potential for Chloramphenicol contamination. | Class II |
| 2014-01-01 | MegaFood Vegan-Ease 30 ct. (12002) and MegaFood Vegan-Ease 2 ct. Sample Pack (S12002) | FoodState (Nutrient Manufacturing) | Potential for Chloramphenicol contamination. | Class II |
| 2014-01-01 | MegaFood Gluten & Dairy Megazymes 30ct. (10218) and MegaFood Gluten & Dairy Megazymes 60ct. (10219) | FoodState (Nutrient Manufacturing) | Potential for Chloramphenicol contamination. | Class II |
| 2014-01-01 | KARIKAS ORTHOMOLECULAR NUTRITION MegaZymes Plus (High Concentration) (LK10528) | FoodState (Nutrient Manufacturing) | Potential for Chloramphenicol contamination. | Class II |
| 2014-01-01 | MegaFood High Active Enzymes - 30 count (Formula 10216) | FoodState (Nutrient Manufacturing) | Potential for Chloramphenicol contamination. | Class II |
All 6 records for FoodState (Nutrient Manufacturing)
All 2014 recalls · All FDA food recall data
Behind every recall is a clause 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.