Cellulase: ACTA 4-702 APEX 17-6262 APEX 6-9762 ARTH EB 10831 BETA GLUC...
FDA Recall #F-0133-2014 — Class II — October 3, 2013
Recall Summary
| Recall Number | F-0133-2014 |
| Date Initiated | October 3, 2013 |
| Classification | Class II |
| Status | Terminated |
| Type | Voluntary: Firm initiated |
| Product Type | Food |
Recalling Firm
| Firm | Specialty Enzymes & Biotechnologies |
| Location | Chino, CA |
Product Description
Cellulase: ACTA 4-702 APEX 17-6262 APEX 6-9762 ARTH EB 10831 BETA GLUCANASE 1000 BROOK 8-352 CELLULASE 1000 CELLULASE 4000 CELLULASE CONC. CENTURY 7-152 CLENZSEB DIGESEB DIGESEB PB DIGESEB PLUS DIGESEB PLUS 401 DIGESEB SUPER DIGESEB SUPER 118 EB 10-14081 EB 10-15351 EB 12-706 EB 14-14201 EB 16-15612 EB 17-14161 EB 5-13302 EB 5-14121 EB 5-15361 EB 8-15731 EB 9-14181 EB 9-14191 EL 5-7212 GLOBAL 8-658 GREENZYME 427 HEMISEB JARL 3-164 NAT 9-185 NF 525 NHK 14-9451 NPC 270 NPC 5005 NPC 6006 NW 7B 9142 PB 10401 SEB GLUTEN RELIEF SEB GLUTEN RELIEF HNS SUPER 108 TUMMYEASE VEGPANZYME PLUS VR 5-8451
Reason for Recall
Specialty Enzymes and Biotechnologies is recalling cellulase/mannanase and fungal protease because they may contain low levels of 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
Nationwide in US and worldwide to: Australia, Canada, Malaysia, Taiwan, Italy
Product Quantity
33247.5kg
Product Codes / Lot Numbers
Lot Numbers: 3051077 3031052; 3061042 3041028 3041002 3031048 3041011 3041032 3031046 3021019 3021026; 3021053 3071063 3031064 3051045 3041039; 3031054 3031038 3031051 3021067; 3061049 3041012 3021073; 3031017 3071054 3041020 3081005 3021074; 3071059 3071007 3021048; 3041047 3021072; 3031016 3051028 3041021 3031033 3081009 3021015; 3021016 3041057 3051027; 3061019; 3071046; 3031063 3031058 3031022; 3041085 3071071; 3071072 3041055 3021032; 3021033; 3051089 3021022 3021035 3021066 3021041; 3031072; 3031073; 3021039 3021042 3041014; 3041058 3031047 3031018 3031025 3031021; 3041045
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.