Recall · openFDA Food Enforcement

Addback Tablet Dietary Supplement 60 tablets per 190cc Oblong…: FDA Recall F-1295-2019

Agency action: Mar 29, 2019Record ID: F-1295-2019
View official source ↗

What happened

Original notice title

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…

From the archived source record

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

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

Read the official notice →

Status and source details

Status recorded in the archive
Terminated
FDA recall classification
Class II
Recall initiated by
Voluntary: Firm initiated
Report date
Apr 24, 2019
Termination date in the archive
Jan 22, 2020
Source checked
Jul 16, 2026
Record revision
543ccbc0fd3b

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

Sources, dates, and coverage →

What is affected

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
Company
Cays LLC
Lot / identifier
Code NS-1930F Lot # 1810553 Exp. Date 12/2020
Market / distribution
All product is in the firm's possession.