Xylanase Enzyme Blends, bulk, custom blended formulations identified as xylan...

FDA Recall #F-0178-2014 — Class II — September 26, 2013

Recall Summary

Recall NumberF-0178-2014
Date InitiatedSeptember 26, 2013
ClassificationClass II
StatusTerminated
TypeVoluntary: Firm initiated
Product TypeFood

Recalling Firm

FirmBio-Cat Inc
LocationTroy, VA

Product Description

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: [email protected] 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.

Classification

Class II — A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Distribution Pattern

The products were distributed to manufacturers and distributors nationwide and to Canada.

Product Quantity

3276 kg total for all products

Product Codes / Lot Numbers

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

What Should You Do?

Stop consuming this product immediately. Check your home for the recalled item and dispose of it safely. If you experienced a health issue after consuming this product, contact your doctor and report it to the FDA MedWatch.

Frequently Asked Questions

Stop consuming the product immediately and do not donate or give it to others. Check the recall notice above for specific disposal or return instructions. Many food recalls ask you to throw the product away and retain the packaging for a possible refund from the retailer. If you purchased it online, check your order history — some retailers send recall notifications directly to customers. You do not need a receipt to report an issue or seek a refund; the fact of purchase is typically sufficient.

In most cases, yes. Retailers are typically notified to accept returns of recalled products and issue refunds, regardless of whether you have a receipt. Check with the store where you purchased the item. Some manufacturers also offer direct refunds — contact the recalling firm using the information in the official recall notice. If you purchased the product online, contact the retailer's customer service with your order number. In either case, you generally do not need original packaging, though retaining the product label with the lot code or UPC can speed up the process.

Report foodborne illnesses and adverse food reactions to the FDA through the MedWatch Safety Reporting Portal at FDA.gov, or by calling 1-800-332-1088. You can also report issues directly to the FDA's Safety Reporting Portal at SafetyReporting.hhs.gov. If you believe there is an immediate public health risk, contact your local health department. Your report helps the FDA identify contamination patterns, initiate recalls faster, and protect other consumers from the same hazard. Include as much detail as possible: the product name, lot code, purchase date and location, and a description of your symptoms or findings.

The FDA assigns a status to each recall action throughout its lifecycle. "Ongoing" means the recall is active — the firm is still working to remove the product from commerce and notify consumers. "Completed" means the recall strategy has been implemented and the FDA has determined that the recalling firm has taken all appropriate steps to remove the product. "Terminated" means the FDA has reviewed the results and concluded the recall is complete. Even if a recall is marked as completed or terminated, you should still discard any recalled products you find at home — the recall status refers to the firm's compliance actions, not the safety of product still in consumers' possession.