Food recall: Serene Science/Source Naturals brand GABA (Gamma-Aminobutyric Acid), CALM MIND, A dietary supplement, 45 Tablets, Item…
Class II FDA enforcement event 66564. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The firm found small piece of metal fragment in one tablet during its inspection process.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Threshold Enterprises Ltd started this food recall on 20 Sep 2013. The firm address in the FDA record is in Scotts Valley, CA. FDA put the recall in Class II. FDA event 66564 has 1 product record. The first FDA enforcement report date is 13 Nov 2013. The record gives the status Terminated, with the termination date 27 Jan 2014.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
The product was distributed Nationwide.
Recalling firm
Threshold Enterprises Ltd, Scotts Valley, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| F-0100-2014 | Serene Science/Source Naturals brand GABA (Gamma-Aminobutyric Acid), CALM MIND, A dietary supplement, 45 Tablets, Item #: SN0237; 90 Tablets, Item #: SN0240; 180 Tablets, Item #: SN0268; Product label states, "manufactured for Source Naturals, Inc., P.O. Box 2118, Santa Cruz, CA 95062"; and distributed by Threshold… | 3976 bottles | Class II | Terminated | 13 Nov 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Food events that started in 2013
- 546
- Share of these events in Class II
- 52%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 10 Sep 2019 | Source Naturals Dietary Supplement Brain Charge Advanced Cognitive Support 30 tablets, 60 tablets Manufactured for: Sour | Food | Class III | 1 |
| 7 Dec 2018 | Planetary Herbals Mullein Lung Complex; 1000 mg; 15 count, item number PF0003; 90 count - Item number PF0002; 180 count, | Food | Class II | 1 |
| 16 Jun 2017 | Planetary Herbals Ginseng Classic; Classic Chinese Energizer 710 mg; 60 and 120 UPC 0 21078 10215 1 tablet bottles; 60 c | Food | Class II | 1 |
| 12 Dec 2016 | Source Naturals Dietary Supplement Vitamin D-3; Bioactive Form for Bone and Immune Health 2000 IU per serving, 500% DV. | Food | Class II | 1 |
| 11 Sep 2015 | Source Naturals Hydrogen Boost Capsule: 6 Count Trial, 30 Count, 60 Count; Ingredient: Maltodextrin, Cellulose (Capsules | Food | Class II | 2 |
| 22 Nov 2013 | Source Naturals Essential Enzyme Ultra VEGI-CAP: Premium Digestive Enzyme Blend; 30, 60, 90 & 120 count bottles. Vegetar | Food | Class II | 1 |
Official channels
- FDA enforcement report F-0100-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA: report a problemThe FDA page that shows where a report about a product goes.
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Cite this page
Recall Register. FDA enforcement event 66564. https://recallregister.com/fda/ii/66564/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA food enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
The product was distributed Nationwide.
- What quantity of product is in FDA event 66564?
- The FDA record gives this quantity:
3976 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many food recalls of 2013 have the same class?
- 52% of the 546 food events that started in 2013 are in Class II.