Total Enzyme, Dietary Supplement, Nutri-West, 120 capsules, Servicing Size 1 Capsule
Nutrition Center, Inc. dba Nutri-West recalled this product and the FDA reported the enforcement action on 25 June 2014 as Class II. The recall was initiated by the firm. Nutrition Center voluntarily recalled Total Enzymes and Total Probiotics after notification from supplier that raw materials may potentially contain 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
- Total Enzyme, Dietary Supplement, Nutri-West, 120 capsules, Servicing Size 1 Capsule
- Reason for recall
- Nutrition Center voluntarily recalled Total Enzymes and Total Probiotics after notification from supplier that raw materials may potentially contain Chloramphenicol.
- Recalling firm
- Nutrition Center, Inc. dba Nutri-West
- Firm location
- Douglas, Wyoming, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-2031-2014
- Quantity
- 8,414 bottles
- Distribution
- NATIONWIDE, ENGLAND, no military/govt/VA consignees.
- Initiated
- 10 October 2013
- Reported by FDA
- 25 June 2014
- Terminated
- 11 July 2014
- Firm notified by
- Product codes
- TOTAL ENZYMES Product # 2404 LOT#S 302152, 303083, 306046, 308044(PARTIAL)
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. 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 2 of them.
- The recall ran for 9 months, from 10 October 2013 to termination on 11 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 8 months 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.
Filed under dietary supplements. A product can sit in more than one.
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.
Other records from Nutrition Center, Inc. dba Nutri-West
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2014-06-25 | Total Probiotics, Dietary Supplement, Nutri-West, 50 Capsules, Servicing Size 1 Capsule | Nutrition Center, Inc. dba Nutri-West | Nutrition Center voluntarily recalled Total Enzymes and Total Probiotics after notification from supplier that raw materials may potentially contain Chloramphenicol. | Class II |
All 2014 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.