Recall record at a glance
| Official record | F-0100-2014 |
|---|---|
| Category | Food Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Threshold Enterprises Ltd |
| Report date | Nov 13, 2013 |
| Recall initiation date | Sep 20, 2013 |
| Quantity | 3976 bottles |
| Location | Scotts Valley, CA, United States |
Official product description
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
Why the product was recalled
The firm found small piece of metal fragment in one tablet during its inspection process.
Distribution information
The product was distributed Nationwide.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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