Super Digestayme, 200 count, 2 boxes x 72 bottles, 1 box x 55 bottles. 300 count, 4…

Global Vitality, Inc. dba Enzyme Process International recalled this product and the FDA reported the enforcement action on 19 March 2014 as Class II. The recall was initiated by the firm. Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol. The dietary supplements were made with a raw ingredient that was on recalled by Specialty Enzymes & Biotechnologies due to chloramphenicol.

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

Super Digestayme, 200 count, 2 boxes x 72 bottles, 1 box x 55 bottles. 300 count, 4 boxes x 72 bottles, 1 box x 12 bottles.

Reason for recall

Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol. The dietary supplements were made with a raw ingredient that was on recalled by Specialty Enzymes & Biotechnologies due to chloramphenicol.

Recalling firm

Global Vitality, Inc. dba Enzyme Process International

Firm location

Chandler, Arizona, United States

Classification

Class II

Status

Terminated

Recall number

F-1642-2014

Quantity

69,800 units

Distribution

PA, AZ, HI,

Initiated

22 October 2013

Reported by FDA

19 March 2014

Terminated

5 November 2014

Firm notified by

E-Mail

Product codes

Lot 1585

Reading this record

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

• Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. 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 9 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 9 separate recalls, which almost every published figure does, overstates it by a factor of 9. 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 9 of them.
• The recall ran for 12 months, from 22 October 2013 to termination on 5 November 2014. 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 distribution pattern names 3 states, and the FDA published the enforcement report 5 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.

Named in the distribution pattern: Pennsylvania, Arizona, Hawaii. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.

Other records from Global Vitality, Inc. dba Enzyme Process International

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 8 other records name this firm.

All 9 records for Global Vitality, Inc. dba Enzyme Process International

All 2014 recalls · All FDA food recall data