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Threshold Enterprises Ltd Recall: Dietary supplements contain low levels of undeclared boron

United States

TerminatedClass II

Company
Threshold Enterprises Ltd
Product
Source Naturals Renewal Antioxidant Tablet: 10 Count Sample…
Recall date
September 11, 2015
Terminated
July 10, 2017
Source
FDA

Reason for recall

Dietary supplements contain low levels of undeclared boron

  1. - Recall initiated
  2. - Reported by source
  3. - Recall terminated
Recalled products
Product description UPC Quantity Lot / code information
Source Naturals Renewal Antioxidant Tablet: 10 Count Sample Pack, 30 Count, 60 Count, & 120 Count per bottle; Ingredient: Maltodextrin, Cellulose (Capsules, Silica and magnesium stearate; 30 count Bottle - Product SN1750: 60 count Bottle - Product SN1751; 120 count Bottle - Product SN1752; 10 Count Sample Packs - Product SN5024. Manufactured for Source Naturals, Santa Cruz, CA Not published in this source record 9,361 units 30 Count bottles: Lot No. QTY Exp. FG-13852 76 12/15 FG-14726 148 12/15 FG-19274 148 03/16 FG-24304 148 03/16 FG-30636 100 03/16 FG-37569 9 03/16 FG-39616 172 07/17 FG-47423 64 07/17 FG-50614 70 07/17 FG-65266 60 07/17 FG-65266 60 07/17 FG-59256 144 09/18 60 count bottles: Lot No. QTY Exp. FG-13853 338 12/15 FG-14725 468 12/15 FG-19145 290 03/16 FG-23361 206 03/16 FG-23362 396 03/16 FG-34451 98 03/16 FG-38199 38 03/16 FG-39615 424 07/17 FG-50331 122 07/17 FG-53623 144 07/17 FG-59257 362 09/18 FG-65017 206 09/18 120 count bottles: LOT QTY EXP FG-13854 134 12/15 FG-14556 141 12/15 FG-15360 213 12/15 FG-19882 302 03/16 FG-23397 350 03/16 FG-29559 160 03/16 FG-32109 215 03/16 FG-32109 215 03/16 FG-37240 60 03/16 FG-38639 42 03/16 FG-39812 444 07/17 FG-45840 266 07/17 FG-51761 200 07/17 FG-59258 482 09/18 FG-64221 218 09/18 FG-65613 395 09/18; 10 count sample packs; Lot No. QTY Exp. FG-13855 41 12/15 FG-30136 108 03/16 FG-34834 95 03/16 FG-39626 200 07/17 FG-43530 277 07/17 FG-51677 150 07/17 FG-59259 362 09/18

Distribution

  • Nationwide only.

Official source record

Agency
FDA
Dataset
FDA Food Enforcement (Recalls)
Recall number
F-2383-2017
Event ID
77531
Status
Terminated
Classification
Class II
Company
Threshold Enterprises Ltd
Product description
Source Naturals Renewal Antioxidant Tablet: 10 Count Sample Pack, 30 Count, 60 Count, & 120 Count per bottle; Ingredient: Maltodextrin, Cellulose (Capsules, Silica and magnesium stearate; 30 count Bottle - Product SN1750: 60 count Bottle - Product SN1751; 120 count Bottle - Product SN1752; 10 Count Sample Packs - Product SN5024. Manufactured for Source Naturals, Santa Cruz, CA
Quantity
9,361 units
Reason
Dietary supplements contain low levels of undeclared boron
Recall initiation date
September 11, 2015
Report date
July 19, 2017
Classification date
Not published in this source record
Termination date
July 10, 2017
Distribution pattern
Nationwide only.
UPC, lot, and code information
30 Count bottles: Lot No. QTY Exp. FG-13852 76 12/15 FG-14726 148 12/15 FG-19274 148 03/16 FG-24304 148 03/16 FG-30636 100 03/16 FG-37569 9 03/16 FG-39616 172 07/17 FG-47423 64 07/17 FG-50614 70 07/17 FG-65266 60 07/17 FG-65266 60 07/17 FG-59256 144 09/18 60 count bottles: Lot No. QTY Exp. FG-13853 338 12/15 FG-14725 468 12/15 FG-19145 290 03/16 FG-23361 206 03/16 FG-23362 396 03/16 FG-34451 98 03/16 FG-38199 38 03/16 FG-39615 424 07/17 FG-50331 122 07/17 FG-53623 144 07/17 FG-59257 362 09/18 FG-65017 206 09/18 120 count bottles: LOT QTY EXP FG-13854 134 12/15 FG-14556 141 12/15 FG-15360 213 12/15 FG-19882 302 03/16 FG-23397 350 03/16 FG-29559 160 03/16 FG-32109 215 03/16 FG-32109 215 03/16 FG-37240 60 03/16 FG-38639 42 03/16 FG-39812 444 07/17 FG-45840 266 07/17 FG-51761 200 07/17 FG-59258 482 09/18 FG-64221 218 09/18 FG-65613 395 09/18; 10 count sample packs; Lot No. QTY Exp. FG-13855 41 12/15 FG-30136 108 03/16 FG-34834 95 03/16 FG-39626 200 07/17 FG-43530 277 07/17 FG-51677 150 07/17 FG-59259 362 09/18
Voluntary or mandated
Voluntary: Firm initiated
Initial notification method
Telephone
Source last updated
Not tracked separately from the Public Health Trace retrieval date below
Public Health Trace retrieval date

Other products recalled under this same event

This recall shares FDA event ID 77531 with 1 other product entry in Public Health Trace.

FDA Recall United States Terminated Historical recordClass II

Threshold Enterprises Ltd

Product
Source Naturals Hydrogen Boost Capsule: 6 Count Trial, 30…
Published
July 19, 2017
Distribution
Nationwide

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Responsible company: Threshold Enterprises Ltd

Other recalls from Threshold Enterprises Ltd

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Product
Source Naturals Dietary Supplement Brain Charge Advanced…
Published
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Distribution
U.S. distribution to the following: AL,…

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Product
Planetary Herbals Mullein Lung Complex; 1000 mg; 15 count,…
Published
March 6, 2019
Distribution
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FDA Recall United States Terminated Historical recordClass II

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Product
Planetary Herbals Ginseng Classic; Classic Chinese Energize…
Published
August 9, 2017
Distribution
CA, MN, WA, IL, PR, ME, SD.

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Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class II mean?

A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.

Is this recall still active?

According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this product?

Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.

Where can I find more official information?

The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.