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Recall Observatory FDA recall evidence

Food product

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

F-0100-2014

September 20, 2013

Class II

Product summary

Firm
Threshold Enterprises Ltd
Event
Event 66564
Status
Terminated
Classification
Class II
Quantity
3976 bottles
Official record key
food-enforcement:F-0100-2014

Official wording

Reason: The firm found small piece of metal fragment in one tablet during its inspection process.

Code information: 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

Distribution pattern: The product was distributed Nationwide.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    piece of metal