Food recall

Threshold Enterprises Ltd recall: Serene Science/Source Naturals brand GABA (Gamma-Aminobutyric Acid), CALM MIND, A dietary supplement

Threshold Enterprises Ltd, of Scotts Valley, CA, recalled Serene Science/Source Naturals brand GABA (Gamma-Aminobutyric Acid), CALM MIND, A dietary supplement. The FDA's reason: “The firm found small piece of metal fragment in one tablet during its inspection process.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on September 20, 2013, and the FDA first listed it in its Enforcement Report of November 13, 2013. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

Metal, plastic, glass or other objects

Status

Terminated

Closed January 27, 2014

The recall

Company
Threshold Enterprises Ltd (Scotts Valley, CA)
Reason, in FDA's words
“The firm found small piece of metal fragment in one tablet during its inspection process.”
Where it was sold
The product was distributed Nationwide.
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
66564

The product recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-0100-2014 Class II

    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 Enterprises, Ltd, Scotts Valley, CA; The product is actually manufactured by a Contract Manufacturer: Abco Laboratories, Inc., 2450 S. Watney Way, Fairfield, CA 94533

    Codes: Item #: SN0237 - 45 Count, Lot Numbers: FG-40244, FG-40421, FG-40679; Item #: SN0240 - 90 Count, Lot Numbers: FG-40245, FG-40422, FG-40680; Item #: SN0268 -180 Count Lot Number: FG-40681; All packages have BEST BY DATE 3/21/17

    Quantity: 3976 bottles

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of November 13, 2013.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.