Xylanase Enzyme Blends, bulk, custom blended formulations identified as xylanase 1000…
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
- Xylanase Enzyme Blends, bulk, custom blended formulations identified as xylanase 1000, xylanase 150,000 XU, synerzyme-ae, brizyme, Cellulase Special Blend OMRI, xylanase amylase blend, Bio-Cat Ruminant Enzyme, Feed Blend ws alkacel 20x, BC-XR, enzyme blend #2237, CHX blend, EB-7 multi-enzyme blend EB110311-01, EB020812-01, xylanase 70,000, nut 14-500, ultra blend 102 xylanase 10,000, bb cd blend #3, soy blend, amiron blend, Formula #121412b, erc530b, pn digestive blend, digest basic, blend 0313, xylanase 20,000, EC-CHPX, Xylanase 50,000 XU, Xylanase 50m XU, Xylanase 25,000, Xylanase 190,000 XU, af-5x, silage blend, xylanase concentrate, Enzyme Blend 1, and Enzyme Blend 2, packed in boxes or drums ranging from 1 kg to 25 kg, item # XYXP, 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-0178-2014
- 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: xy150-vw08 synae-vw18 synae-vw19 synae-vw20 xy150-tw14 bri-xw16 xy150-tw22 xy150-yw05 csbomri-xw20 xab-vw21 xab-aw07 bcr-yw14 bcr-aw05 fbws-uw04 fbws-aw02 alc20-ww05 xy150-xw30 bcxr-tw04 bcxr-ww12-a (375)/bcxr-ww12-b (125) bcxr-yw27 bcxr-aw15 eb2237-vw14 chxb-uw27 xy150-zw17 xy150-tw15 xy150-uw21 xy150-xw02 xyc-yw06 xy150-uw26 ali13008-01 ali13008-02 ali13008-13 ali13036-01 ali13053-05 ali13071-01 ali13071-02 ali13140-02 ali13140-03 ali13200-08 ali13200-09 ali13212-04 ali13157-11 ali13206-05 ali13206-06 bbcdb-vw25 bbcdb-xw02 soyb-tw21 soyb-zw02 xy150-tw16 xy150-vw14 xy150-ww08 amib-uw06 amib-uw13 f121412b-vw13 erc530b-xw22 xy150-aw13 xy150-aw20 pndb-xw28 xy150-tw23 db-bw12 b0313-vw22 xy10-uw15 xy20-ww02 xy10-xw20 ecchpx-zw18 xy50-tw09 xy150-tw09 xy50-tw09 xy150-tw16 xy150-vw22 xy150-ww05 xy50-ww09 xy150-ww22 xy150-xw23 xy150-yw24 xy150-zw02 xy50-zw11 xy150-zw19 xy150-aw07 xy50-aw23 xy25-xw22 xy200-vw22 xy150-uw20 af5x-uw04 sb-xw09 xy150-uw08 xy01-vw11 xyc-ww24 xyc-ww18 eb1-yw03 eb2-yw03
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. All 3 of them are listed on this page.
- 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.
Every product in this recall
The FDA opened 3 enforcement records for this one recall, one per product code. This page carries all of them; the 2 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.
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.