Recalls / Class II
Class IIF-0100-2014
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
- Type
- Food
- Affected lot / code info
- 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
Why it was recalled
The firm found small piece of metal fragment in one tablet during its inspection process.
Recalling firm
- Firm
- Threshold Enterprises Ltd
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 23 Janis Way, N/A, Scotts Valley, California 95066-3506
Distribution
- Distribution pattern
- The product was distributed Nationwide.
Timeline
- Recall initiated
- 2013-09-20
- FDA classified
- 2013-11-01
- Posted by FDA
- 2013-11-13
- Terminated
- 2014-01-27
- Status
- Terminated
Source: openFDA Food Enforcement endpoint. Recall record F-0100-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings.