PlainRecalls
FDA Food Moderate Class II Terminated

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

Reported: April 24, 2019 Initiated: March 29, 2019 #F-1295-2019

Product Description

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

Details

Recalling Firm
Cays LLC
Units Affected
2095 bottles
Distribution
All product is in the firm's possession.
Location
Southington, CT

Frequently Asked Questions

What product 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. Recalled by Cays LLC. Units affected: 2095 bottles.
Why was this product 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
Which agency issued this recall?
This recall was issued by the FDA Food on April 24, 2019. Severity: Moderate. Recall number: F-1295-2019.