Nutritional Frontiers Cyb Zyme- A Dietary Supplement for Complete Digestive Support 90…
FoodScience Corporation recalled this product and the FDA reported the enforcement action on 4 December 2013 as Class II. The recall was initiated by the firm. Dietary supplements are recalled because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains 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
- Nutritional Frontiers Cyb Zyme- A Dietary Supplement for Complete Digestive Support 90 count
- Reason for recall
- Dietary supplements are recalled because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol.
- Recalling firm
- FoodScience Corporation
- Firm location
- Essex Junction, Vermont, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0227-2014
- Quantity
- 144 units
- Distribution
- NJ
- Initiated
- 8 November 2013
- Reported by FDA
- 4 December 2013
- Terminated
- 21 January 2014
- Firm notified by
- Letter
- Product codes
- Lot Number: 20165800
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 4 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 4 separate recalls, which almost every published figure does, overstates it by a factor of 4. 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 4 of them.
- The recall ran for 2 months, from 8 November 2013 to termination on 21 January 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 1 state, and the FDA published the enforcement report 4 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.
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 FoodScience Corporation
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2019-07-31 | DaVinci Laboratories of Vermont Omega 3-1,000 in a white bottle labeled as Dim Plex, 60 count UPC Code 026664273161 | FoodScience Corporation | Dietary supplement mislabeled, undeclared allergen. | Class II |
| 2013-12-04 | Florayme A Dietary Supplement for Complete Digestive Support, 90 count capsules Distributed by Wendy Huang, MD, MPH, DABMA 9 Professional Circle, Suite 212, Colts Neck, NJ 07722 | FoodScience Corporation | Dietary supplements are recalled because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol. | Class II |
| 2013-12-04 | Cenk Disczyme A Dietary Supplement for Complete Digestive Support, 180 count capsule Distributed by Cenk Integrated Health & Spine Services, 107 Gamma Drive Ste 100, Pittsburgh, PA 15328 | FoodScience Corporation | Dietary supplements are recalled because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol. | Class II |
| 2013-12-04 | Life Worth Living Nutriceuticals LWL Enzyme Life A Dietary Supplement for Complete Digestive Support, Distributed by Life Worth Living Nutriceuticals, 6488 Currin Drive, Orlando, Florida 32835 90 count | FoodScience Corporation | Dietary supplements are recalled because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol. | Class II |
All 5 records for FoodScience Corporation
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.