Cellulase Enzyme Blends, bulk, custom blended formulations identified as Cellulase BX…
Bio-Cat 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. Raw material enzymes intended for further manufacturing of foods and dietary spplements may be 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
- Cellulase Enzyme Blends, bulk, custom blended formulations identified as Cellulase BX and Celluase Conc, packed in boxes or drums ranging from 1 kg to 25 kg, item # CELIND, labeled in part ***Manufactured by BIO-CAT, INC.9117 Three Notch Road Troy, Virginia 22974 Telephone (800) 545-9052 Fax (434) 589-3301 E-mail: info@bio-cat.com Website: www.bio-cat.com***
- Reason for recall
- Raw material enzymes intended for further manufacturing of foods and dietary spplements may be contaminated with chloramphenicol.
- Recalling firm
- Bio-Cat Inc
- Firm location
- Troy, Virginia, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0176-2014
- Quantity
- 3276 kg total for all products
- Distribution
- The products were distributed to manufacturers and distributors nationwide and to Canada.
- Initiated
- 26 September 2013
- Reported by FDA
- 27 November 2013
- Terminated
- 17 June 2014
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Lots: fsb-tw07 fsb-uw14 fsb-vw08 pob-tw31 pob-vw27 pob-xw23 pob-aw05 cbx-yw12 cbx-xw06 cbx-xw10 cbx-aw09 ccu-yw06
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 3 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 3 separate recalls, which almost every published figure does, overstates it by a factor of 3. 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 3 of them.
- The recall ran for 9 months, from 26 September 2013 to termination on 17 June 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 2 months after the firm began the recall.
- Recalls of pet or animal food run a median of 8 months, so this one was about typical for its category. Animal food is regulated under its own preventive controls rule at 21 CFR part 507, and a pet food recall is frequently a human health recall too, because Salmonella in dry pet food reaches people through the bowl and the hands rather than through eating it.
Filed under pet and animal food. A product can sit in more than one.
Other pet and animal food 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 Bio-Cat Inc
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
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.