Pectinase Enzyme Blends, bulk, custom blended formulations identified as pectinase 500…
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
- Pectinase Enzyme Blends, bulk, custom blended formulations identified as pectinase 500, pectinase 1000, Pectinase 350 Endo-pg/gm, PC Blend 14, Nut 14-500, pectinase 3500, gastro blend 0111, Digestive Blend 021894, enzyme complex 5763, pectinase 1750, pectinase 350, EC-CHPX, enzyme blend for cyto grn, pectinase 150m, and Cellulase 3, packed in boxes or drums ranging from 1 kg to 25 kg, item # PECCI, 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-0177-2014
- 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: SYNAE-VW18 SYNAE-VW19 SYNAE-VW20 BRI-XW16 E7X-TW03 E7X-UW20 E7XBY-UW21 E7X-WW26 E7XBY-XY07 E7X-YW25 E7X-ZW24 E7X-BW16 PE003-UW21 PE003-XW02 EBY2X-UW22 EBW-VW12 EBW-VW13 EBW-VW14 EBW-XW10 EBW-XW13 EBW-XW14 EBY2X-XW15 EBW-YW11 EBW-YW12 EBW-YW13 EBW-AW19 EBW-AW20 PE350-VW01 PE350-YW19 EBW-AW21 pe05-ww30 ALI13249-03 ali13024-02 ali13036-01 ali13212-04 ali13157-09 bgb0111-vw26 db18-xw24 db18-yw04 db18-yw06 db18-aw22 DB18-ZW23 DB18-AW30 ec5763-bw06 pe035-tw23 peo35-tw14 pe1750-vw11 pe350-vw11 ECHPX-ZW18 pe350-xw22 pe350-aw13 ebcyto-yw28 ebcyto-aw09 ebcyto-bw19 pe150-vw20 pe150-bw05 cell3-ww18 cell3-xw07 cell3-aw01 cell3-AW14 pe01-uw07 pe035-yw07 EB7-XW08 EB7-AW23
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 nuts or seeds run a median of 7 months, so this one was longer than usual for its category. Nuts and seeds carry both hazards at once: they are a major allergen in their own right, and as a low-moisture food they hold Salmonella for months without supporting its growth, which is why a nut butter recall can trace to a lot pressed a year earlier.
Filed under nuts and seeds and pet and animal food. A product can sit in more than one.
Other nuts and seeds 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.