Lifeforce Medical Institute Ultra Power; Optimal Vitamin/Mi neral. Trace…
ProThera, Inc. recalled this product and the FDA reported the enforcement action on 27 November 2013 as Class II. The recall was initiated by the firm. Firm was notified by supplier of the enzyme Xylanase that it was contaminated with 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
Lifeforce Medical Institute Ultra Power; Optimal Vitamin/Mi neral. Trace Element/Anti-Oxidant Detox Support Dietary Supplement. 10 tablets/Packet and 30 packets/1000cc bottle. Distributed by: Mark Rosenbloom, MD LIFEFORCE Medical Institute 60 Revere Dr., Ste. 820 Northbrook, IL 60062 (847) 905-9505 www.lifeforcemed.com
Reason for recall
Firm was notified by supplier of the enzyme Xylanase that it was contaminated with chloramphenicol.
US and Canada, Germany, Great Britain, Hong Kong, Malaysia, Mexico, Philippines, Russia, Singapore, South Korea , Spain
Initiated
6 November 2013
Reported by FDA
27 November 2013
Terminated
16 July 2014
Firm notified by
Letter
Product codes
361849A, Product code CT-80924A
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 2 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 2 separate recalls, which almost every published figure does, overstates it by a factor of 2. All 2 of them are listed on this page.
The recall ran for 8 months, from 6 November 2013 to termination on 16 July 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 FDA published the enforcement report 3 weeks after the firm began the recall.
Recalls of a dietary supplement run a median of 15 months, so this one was shorter than usual for its category. Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.
The FDA opened 2 enforcement records for this one recall, one per product code. This page carries all of them; the 1 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.
Firm was notified by supplier of the enzyme Xylanase that it was contaminated with chloramphenicol.
Class II
Other dietary supplements recalls
These are the closest records in the corpus: the same kind of food. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Behind every recall is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.
