Original HCG. 2oz HCG Drops. Amber Glass

Infiniti Creations, LLC recalled this product and the FDA reported the enforcement action on 30 November 2016 as Class III. The recall was initiated by the firm. The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

Product

Original HCG. 2oz HCG Drops. Amber Glass

Reason for recall

The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.

Recalling firm

Infiniti Creations, LLC

Firm location

Lindon, Utah, United States

Classification

Class III

Status

Terminated

Recall number

F-0497-2017

Quantity

4,900 units

Distribution

Nationwide and Canada. No other foreign and military/govt/VA consignees.

Initiated

30 September 2016

Reported by FDA

30 November 2016

Terminated

31 March 2017

Firm notified by

Letter

Product codes

Lots: D051612; D061619; IC0116K; IC0116M

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

• Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
• The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
• This is one of 19 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 19 separate recalls, which almost every published figure does, overstates it by a factor of 19. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 19 of them.
• The recall ran for 6 months, from 30 September 2016 to termination on 31 March 2017. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
• The FDA published the enforcement report 2 months after the firm began the recall.
• The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

What this recall was for

Other records from Infiniti Creations, LLC

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 18 other records name this firm.

All 19 records for Infiniti Creations, LLC

All 2016 recalls · All FDA food recall data