Diatomaceous Earth packaged in the following ways: 1) Perma-Guard, Fossil Shell Flour…
Earthworks Health recalled this product and the FDA reported the enforcement action on 20 March 2019 as Class II. The recall was initiated by the firm. Product contains elevated levels of lead, arsenic, and chromium: potentially harmful metals.
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
- Diatomaceous Earth packaged in the following ways: 1) Perma-Guard, Fossil Shell Flour, Anti-caking agent, Food Chemical Codex Grade, Weight: 50 lb/22.6 kg, Bountiful, UT; 2) 100% Food Grade Diatomaceous Earth, Shell Flour, Packaged by: Earthworks Health, Norfolk, NE, Net Weight 2.5 Pounds 3) 100% Food Grade Diatomaceous Earth, Shell Flour, Packaged by: Earthworks Health, Norfolk, NE, Net Weight 10 pounds
- Reason for recall
- Product contains elevated levels of lead, arsenic, and chromium: potentially harmful metals.
- Recalling firm
- Earthworks Health
- Firm location
- Norfolk, Nebraska, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1160-2019
- Quantity
- N/A
- Distribution
- Product distributed directly to consumers nationwide.
- Initiated
- 4 December 2018
- Reported by FDA
- 20 March 2019
- Terminated
- 5 April 2019
- Firm notified by
- Product codes
- 50 lb containers: lots 18289 & 18323 2.5 lbs and 10 lbs: No codes
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 record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 4 months, from 4 December 2018 to termination on 5 April 2019. 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 3 months after the firm began the recall.
- Recalls of a grain, flour or pasta product run a median of 6 months, so this one was shorter than usual for its category. Flour is a raw agricultural product that consumers treat as though it were cooked, which is the whole reason raw flour recalls exist: nothing in milling is a kill step, and the hazard only appears when somebody eats the dough.
What this recall was for
Chemical contamination
A chemical contamination recall covers a substance that is harmful in food and was never meant to be there: a heavy metal, a cleaning chemical, a pesticide residue, or a natural toxin such as aflatoxin or histamine.
A preventive controls plan covers chemical contamination 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 117.35(b)
- Substances used in cleaning and sanitizing: toxic materials stored, identified and used so they cannot contaminate food, food-contact surfaces or packaging.
- 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.
- 21 CFR 117.130(b)(1)(ii)
- Hazard analysis: identifying the known or reasonably foreseeable chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins and food decomposition.
Filed under grains, flour and pasta. A product can sit in more than one.
Other grains, flour and pasta 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.
All 2019 recalls · All FDA food recall data
21 CFR 117.35(b) 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.