TriEnza bulk powder distributed in a 5 kilogram polyethylene bag.
Houston Nutraceuticals, Inc recalled this product and the FDA reported the enforcement action on 4 December 2013 as Class II. The recall was initiated by the firm. The firm is recalling a dietary supplement containing a raw material which may contain >0.3 ppb of 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
- TriEnza bulk powder distributed in a 5 kilogram polyethylene bag.
- Reason for recall
- The firm is recalling a dietary supplement containing a raw material which may contain >0.3 ppb of chloramphenicol.
- Recalling firm
- Houston Nutraceuticals, Inc
- Firm location
- Siloam Springs, Arkansas, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0381-2014
- Quantity
- 5 kg
- Distribution
- The product was not distributed domestically. The product was distributed Internationally to Brazil
- Initiated
- 8 November 2013
- Reported by FDA
- 4 December 2013
- Terminated
- 12 May 2014
- Firm notified by
- Product codes
- Lot # 83381000
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 record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 6 months, from 8 November 2013 to termination on 12 May 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 4 weeks 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.
All 2013 recalls · All FDA food recall data
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.
Early accessRecall 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.