Class II — Eating this product may cause temporary or medically reversible health problems; serious harm is unlikely.
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
The firm found small piece of metal fragment in one tablet during its inspection process.
| Recall # | Product | Lot / code | Status |
|---|---|---|---|
| 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 Enterprises, Ltd, Scotts Valley, CA; The product is actually manufactured by a Contract Manufacturer: Abco Laboratories, Inc., 2450 S. Watney Way, Fairfield, CA 94533 | 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 | Terminated |
Labeling error; incorrect supplement facts panel and label claims for two ingredients were lower than the product formulation.
Recall of Mullein Lung Complex due to a labeling error which indicates the incorrect excipient profile (inactive ingredients).
Product was inadvertently released prior to release of all QC testing. Testing had positive results for coliform growth.
Testing of Vitamin D-3 as a result of a consumer complaint found specific lots to have lower concentrations than product specifications of ingredient labeling.
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