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Class II: temporary or reversible health riskTerminated

Threshold Enterprises Serene Science/Source Naturals brand GABA Recall

Serene Science/Source Naturals brand GABA (Gamma-Aminobutyric Acid), CALM MIND, A dieta…

Threshold Enterprises Ltd · Scotts Valley, CA

Risk level
Class II
Reported by FDA
Nov 13, 2013
Recall ID
F-0100-2014
Check your lot numberHow we source this data

Summary

Threshold Enterprises recalled Serene Science/Source Naturals brand GABA starting Sep 20, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report F-0100-2014 on Nov 13, 2013. Reason: The firm found small piece of metal fragment in one tablet during its inspection process. Status: Terminated.

Why it was recalled

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

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

Lot numbers, UPCs & expiration 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

Where it was sold

The product was distributed Nationwide.

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-0100-2014
Classification
Class II
Status
Terminated
Recall initiated
Sep 20, 2013
FDA report date
Nov 13, 2013
Quantity
3976 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Threshold Enterprises Ltd

Original FDA data

Every field from FDA enforcement report F-0100-2014, exactly as published.

Show all FDA fields
City
Scotts Valley
State
CA
Status
Terminated
Country
United States
Event ID
66564
Address
23 Janis Way
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
Postal code
95066-3506
Report date
Nov 13, 2013
Product type
Food
Recall number
F-0100-2014
Classification
Class II
Recalling firm
Threshold Enterprises Ltd
Product quantity
3976 bottles
Termination date
Jan 27, 2014
Reason for recall
The firm found small piece of metal fragment in one tablet during its inspection process.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
The product was distributed Nationwide.
Recall initiation date
Sep 20, 2013
Initial firm notification
Letter
Center classification date
Nov 1, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-0100-2014, published Nov 13, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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