FDA recall F-1295-2019

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

Reason for recall

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

Distribution

All product is in the firm's possession.

Key facts

Status

Terminated

Initiation date

2019-03-29

Report date

2019-04-24

Termination date

2020-01-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Southington, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1295-2019