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Class II: temporary or reversible health riskTerminated

Cays Addback Tablet Dietary Supplement 60 tablets Recall

Addback Tablet Dietary Supplement 60 tablets per 190cc Oblong WHDPE bottle Net Wet…

Cays LLC · Southington, CT

Risk level
Class II
Reported by FDA
Apr 24, 2019
Recall ID
F-1295-2019
Check your lot numberHow we source this data

Summary

Cays recalled Addback Tablet Dietary Supplement 60 tablets starting Mar 29, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report F-1295-2019 on Apr 24, 2019. 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. Status: Terminated.

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

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

All product is in the firm's possession.

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-1295-2019
Classification
Class II
Status
Terminated
Recall initiated
Mar 29, 2019
FDA report date
Apr 24, 2019
Quantity
2095 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Cays LLC

Original FDA data

Every field from FDA enforcement report F-1295-2019, exactly as published.

Show all FDA fields
City
Southington
State
CT
Status
Terminated
Country
United States
Event ID
82570
Address
107 Macintosh Way
Code information
Code NS-1930F Lot # 1810553 Exp. Date 12/2020
Postal code
06489-2075
Report date
Apr 24, 2019
Product type
Food
Recall number
F-1295-2019
Classification
Class II
Recalling firm
Cays LLC
Product quantity
2095 bottles
Termination date
Jan 22, 2020
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
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
All product is in the firm's possession.
Recall initiation date
Mar 29, 2019
Initial firm notification
Telephone
Center classification date
Apr 17, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-1295-2019, published Apr 24, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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