Cays product recalled over undeclared coating

Recall date

March 29, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Cays LLC recalls Addback Tablet Dietary Supplement 60 tablets per 190cc Oblong WHDPE bottle Net Wet: 85gm (60 tablet wt) UPC- 0651536124…

Recall number

F-1295-2019

FDA classification

Class II

Brand / firm

Cays LLC

Sold / distributed

All product is in the firm's possession.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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