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Recall Observatory FDA recall evidence

Food product

Addback Tablet Dietary Supplement 60 tablets per 190cc Oblong WHDPE bottle Net Wet: 85gm (60 tablet wt) UPC- 0651536124526 Firm name Prevent D Labs Division of CAYS, LLC Southington, CT

F-1295-2019

March 29, 2019

Class II

Product summary

Firm
Cays LLC
Event
Event 82570
Status
Terminated
Classification
Class II
Quantity
2095 bottles
Official record key
food-enforcement:F-1295-2019

Official wording

Reason: Undeclared coating ingredients: HPMC, Triacetin, Titanium Dioxide, FD & C Yellow # 5, FD & C Yellow # 6, FD & C Blue # 1. In addition, the label states Silicon Dioxide, which is not part of the formulation

Code information: Code NS-1930F Lot # 1810553 Exp. Date 12/2020

Distribution pattern: All product is in the firm's possession.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Undeclared coating ingredients: HPMC, Triacetin, Titanium Dioxide, FD & C Yellow # 5, FD & C Yellow # 6, FD & C Blue # 1. In addition, the label states Silicon Dioxide, which is not part of the formulation