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Named company: Threshold Enterprises Ltd
Labeling error; incorrect supplement facts panel and label claims for two ingredients were lower than the product formulation.
Affected lots: Lot Number: FG-99741, FG-100206, FG-99742, FG-100207
Named company: Threshold Enterprises Ltd
Product was inadvertently released prior to release of all QC testing. Testing had positive results for coliform growth.
Affected lots: 60 count lot FG-86688, Exp. 5/21; 120 count lot FG-86689, Exp. 5/21.
Named company: Threshold Enterprises Ltd
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.
Affected lots: 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.
Named company: Threshold Enterprises Ltd
The inspection found that your facility has significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part…
Lot information: not specified in this record.
This is a dated archive, not live monitoring. Results describe this collection; a missing record does not establish safety.
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