Pectinase Enzyme Blends, bulk, custom blended formulations identified as pect...
FDA Recall #F-0177-2014 — Class II — September 26, 2013
Recall Summary
| Recall Number | F-0177-2014 |
| Date Initiated | September 26, 2013 |
| Classification | Class II |
| Status | Terminated |
| Type | Voluntary: Firm initiated |
| Product Type | Food |
Recalling Firm
| Firm | Bio-Cat Inc |
| Location | Troy, VA |
Product Description
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: [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: 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
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.