Recalls / Class III

Class IIIF-1814-2018

Product

FP0292 Confidence Nitro-Cross 60s, UPC# 8 92483 00155 7

Type

Food

Affected lot / code info

Lot# 070616

Quantity

5,650 bottles in US distribution (total for all products)

Why it was recalled

Product contains undeclared ingredients, Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, Polyethylene Glycol 400 and 800 (PEG), Triacetin

Recalling firm

Firm

Confidence Inc./Confidence U.S.A. Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

138 Haven Ave Ste 101, Port Washington, New York 11050-3924

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2018-07-26

FDA classified

2018-08-13

Posted by FDA

2018-08-22

Terminated

2019-10-22

Status

Terminated

Source: openFDA Food Enforcement endpoint. Recall record F-1814-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings.