Indian Gooseberry Alcohol-Free Extract, 2 oz. glass bottle, UPC 722267094379 and Indian…
Secrets Of The Tribe recalled this product and the FDA reported the enforcement action on 2 November 2022 as Class II. The recall was initiated by the firm. Product has elevated level of lead.
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
- Indian Gooseberry Alcohol-Free Extract, 2 oz. glass bottle, UPC 722267094379 and Indian Gooseberry Alcohol-Free Extract, 4 oz. glass bottle, UPC 722267094393, Secrets of the Tribe LLC, PO Box 5264, Denver, CO, 80217
- UPC
- 722267094379
- Reason for recall
- Product has elevated level of lead.
- Recalling firm
- Secrets Of The Tribe
- Firm location
- Commerce City, Colorado, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0073-2023
- Quantity
- N/A
- Distribution
- Nationwide.
- Initiated
- 19 September 2022
- Reported by FDA
- 2 November 2022
- Terminated
- 5 June 2024
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Batch ID: AMY6045 Best Before 01/11/2028
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. All 2 of them are listed on this page.
- The recall ran for 21 months, from 19 September 2022 to termination on 5 June 2024. 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 fresh produce run a median of 7 months, so this one was longer than usual for its category. Fresh produce is the category where contamination arrives before the facility does: irrigation water, soil amendments and field workers are the routes, and nothing downstream of the farm is a kill step for a product eaten raw.
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 fresh produce and dietary supplements. A product can sit in more than one.
Every product in this recall
The FDA opened 2 enforcement records for this one recall, one per product code. This page carries all of them; the 1 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2022-11-02 | Amla Alcohol-Free Extract, 2 oz. glass bottle, UPC 041979376093 and Amla Alcohol-Free Extract, 4 oz. glass bottle, UPC 041979376116, Secrets of the Tribe LLC, PO Box 5264, Denver, CO, 80217 | Secrets Of The Tribe | Product has elevated level of lead. | Class II |
Other fresh produce 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 Secrets Of The Tribe
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2022-11-02 | Amla Alcohol-Free Extract, 2 oz. glass bottle, UPC 041979376093 and Amla Alcohol-Free Extract, 4 oz. glass bottle, UPC 041979376116, Secrets of the Tribe LLC, PO Box 5264, Denver, CO, 80217 | Secrets Of The Tribe | Product has elevated level of lead. | Class II |
All 2022 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.