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Threshold Enterprises Ltd Recall: 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.

United States

TerminatedClass II

Company
Threshold Enterprises Ltd
Product
Source Naturals Dietary Supplement Vitamin D-3; Bioactive…
Recall date
December 12, 2016
Terminated
May 3, 2017
Source
FDA

Reason for recall

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.

  1. - Recall initiated
  2. - Reported by source
  3. - Recall terminated
Recalled products
Product description UPC Quantity Lot / code information
Source Naturals Dietary Supplement Vitamin D-3; Bioactive Form for Bone and Immune Health 2000 IU per serving, 500% DV. Other ingredients: Vegetable Glycerin, Deionized water, citric acid, Natural orange flavor and lemon essential oil. Use 5 drops once daily in a drink. Packed in glass bottles in the following sizes: Unit Size 1 fl. oz. (29.57 mL), UPC 0 21078 02274 9; 2 fl. oz. (59.14 mL) - UPC 0 21078 02275 6 4 fl. oz. (118.28 mL), UPC 0 21078 02276 3 glass bottles: Codes: 1 ounce glass bottle: SN2274; XUB078; 2 ounce glass bottle: SN2275; 4 ounce glass bottle: SN2276. Manufactured for: Source Naturals, Santa Cruz, CA. Not published in this source record 129,331 total units Lot number/expiry date SN22274: 1 oz bottle: FG-77168, 03/19; FG-72299, 09/18; FG-73645, 09/18; FG-63547, 01/18; FG-55486, 08/17; FG-55923, 08/17; FG-59576, 08/17. XUB078: 1 oz. bottle: FG-77171, 03/19; FG-77172, 03/19; FG-77173, 03/19; FG-79391; 03/19; FG-72190, 09/18; FG-72444, 09/18; FG-73746, 09/18; FG-62593, 01/18; FG-64694, 01/18; FG-55489, 08/17; FG-56655, 08/17; FG-57122, 08/17; FG-59131, 08/17. SN2275 - 2 oz. bottle: FG-77169, 03/19; FG-72330, 09/18; FG-73644, 09/18; FG-74819, 09/18; FG-62810, 01/18; FG-65424, 01/18; FG-67336, 01/18; FG-70958, 01/18; FG-71903, 01/18; FG-55487, 08/17; FG-57284, 08/17; FG-57284, 08/17; FG-62591, 08/17. SN2276 - 4 oz. bottle: FG-77170, 03/19; FG-72301, 09/18; FG-74822, 09/18; FG-62834, 01/18; FG-66128, 01/18; FG-69301, 01/18; FG-71174, 01/18; FG-55488, 08/17; FG-57224, 08/17; FG-58614, 08/17; FG-60671, 08/17; FG-61698, 08/17.

Distribution

  • Nationwide

Official source record

Agency
FDA
Dataset
FDA Food Enforcement (Recalls)
Recall number
F-2178-2017
Event ID
77114
Status
Terminated
Classification
Class II
Company
Threshold Enterprises Ltd
Product description
Source Naturals Dietary Supplement Vitamin D-3; Bioactive Form for Bone and Immune Health 2000 IU per serving, 500% DV. Other ingredients: Vegetable Glycerin, Deionized water, citric acid, Natural orange flavor and lemon essential oil. Use 5 drops once daily in a drink. Packed in glass bottles in the following sizes: Unit Size 1 fl. oz. (29.57 mL), UPC 0 21078 02274 9; 2 fl. oz. (59.14 mL) - UPC 0 21078 02275 6 4 fl. oz. (118.28 mL), UPC 0 21078 02276 3 glass bottles: Codes: 1 ounce glass bottle: SN2274; XUB078; 2 ounce glass bottle: SN2275; 4 ounce glass bottle: SN2276. Manufactured for: Source Naturals, Santa Cruz, CA.
Quantity
129,331 total units
Reason
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.
Recall initiation date
December 12, 2016
Report date
May 10, 2017
Classification date
Not published in this source record
Termination date
May 3, 2017
Distribution pattern
Nationwide
UPC, lot, and code information
Lot number/expiry date SN22274: 1 oz bottle: FG-77168, 03/19; FG-72299, 09/18; FG-73645, 09/18; FG-63547, 01/18; FG-55486, 08/17; FG-55923, 08/17; FG-59576, 08/17. XUB078: 1 oz. bottle: FG-77171, 03/19; FG-77172, 03/19; FG-77173, 03/19; FG-79391; 03/19; FG-72190, 09/18; FG-72444, 09/18; FG-73746, 09/18; FG-62593, 01/18; FG-64694, 01/18; FG-55489, 08/17; FG-56655, 08/17; FG-57122, 08/17; FG-59131, 08/17. SN2275 - 2 oz. bottle: FG-77169, 03/19; FG-72330, 09/18; FG-73644, 09/18; FG-74819, 09/18; FG-62810, 01/18; FG-65424, 01/18; FG-67336, 01/18; FG-70958, 01/18; FG-71903, 01/18; FG-55487, 08/17; FG-57284, 08/17; FG-57284, 08/17; FG-62591, 08/17. SN2276 - 4 oz. bottle: FG-77170, 03/19; FG-72301, 09/18; FG-74822, 09/18; FG-62834, 01/18; FG-66128, 01/18; FG-69301, 01/18; FG-71174, 01/18; FG-55488, 08/17; FG-57224, 08/17; FG-58614, 08/17; FG-60671, 08/17; FG-61698, 08/17.
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

Responsible company: Threshold Enterprises Ltd

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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.

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