Dietary Supplements packaged in the following configurations: (1) Healthy Reflections…
National Enzyme Co recalled this product and the FDA reported the enforcement action on 25 December 2013 as Class II. The recall was initiated by the firm. Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb 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
- Dietary Supplements packaged in the following configurations: (1) Healthy Reflections, Amylase Amylolytic Enzymes Dietary Supplement, packaged in 90-capsule bottles (SKU 52896). Firm name on the label is Healthy Reflections a division of Healthy Alternatives, Garfield, MN; (2) 6895 Hlthy Alternatives Amyl, packaged in 90-capsule unlabeled bottles (SKU 54328)
- Reason for recall
- Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol
- Recalling firm
- National Enzyme Co
- Firm location
- Forsyth, Missouri, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0752-2014
- Quantity
- 1187 bottles
- Distribution
- Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.
- Initiated
- 30 October 2013
- Reported by FDA
- 25 December 2013
- Terminated
- 3 March 2015
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Lot #'s: 52896006 and 54328000
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 81 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 81 separate recalls, which almost every published figure does, overstates it by a factor of 81. 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 81 of them.
- The recall ran for 16 months, from 30 October 2013 to termination on 3 March 2015. 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 weeks after the firm began the recall.
- Recalls of a dietary supplement run a median of 15 months, so this one was about typical 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 National Enzyme Co
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 80 other records name this firm.
All 81 records for National Enzyme Co
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.