Sonne's Detoxificant #7, 1 quart (946 mL) packaged in amber glass bottle.
Anatox Inc recalled this product and the FDA reported the enforcement action on 5 July 2023 as Class III. The recall was initiated by the firm. Elevated lead levels
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
- Sonne's Detoxificant #7, 1 quart (946 mL) packaged in amber glass bottle.
- Reason for recall
- Elevated lead levels
- Recalling firm
- Anatox Inc
- Firm location
- Richland, Missouri, United States
- Classification
- Class III
- Status
- Terminated
- Recall number
- F-1006-2023
- Quantity
- 2,870 bottles
- Distribution
- Distributors, retailers, and consumers in AL, AZ, CA, CT, CO, FL, GA, IL, IN, KS, KY, MA, MD, MN, MO, NC, NM, NY, OH, OR, PA, TN, TX, UT, VA, VT, WI
- Initiated
- 26 May 2023
- Reported by FDA
- 5 July 2023
- Terminated
- 4 October 2023
- Firm notified by
- Letter
- Product codes
- 021424-1, 021724-4
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. 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 26 May 2023 to termination on 4 October 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 distribution pattern names 26 states, and the FDA published the enforcement report 6 weeks after the firm began the recall.
- The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.
Named in the distribution pattern: Arizona, California, Connecticut, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, New Mexico, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin. 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
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.
Other records from Anatox Inc
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2023-07-05 | 1. VIT-RA-TOX Calphonite #38, 15 Fl. oz. (444 ml) in an amber glass bottle; 2. Sonne's Calphonite #2, 15 Fl. oz. (444 ml) in an amber glass bottle | Anatox Inc | Elevated lead levels | Class III |
All 2023 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.