Cellulase & Protease: APEX 10-639 A DIGESEB DIGESEB PLUS DIGESEB SUPER ...
FDA Recall #F-0135-2014 — Class II — October 3, 2013
Recall Summary
| Recall Number | F-0135-2014 |
| 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 & Protease: APEX 10-639 A DIGESEB DIGESEB PLUS DIGESEB SUPER EB 10-14171 EB 10-16192 EB 12-11331 EB 12-9205 EB 14-14201 EB 15-13662 EB 18-13081 EB 7-12831 EB 7-12901 EB 7-14211 EB 8-15731 EL 5-7212 ENZIGEST N FIZYME # 1209 N GLOBAL 8-658 HERB 10-6973 HFI 4-7601 HFN 7-7113 META 10-185 NB 6-7812 NF 525 NHK 14-9451 NPC 7007 NPC 8008 NUTRO 8-7961 OHS - 9804 PROTHERA 18-9724 PROTHERA 19-9723 PROTHERA 8-12182 SD 7-581 SEB GLUTEN RELIEF SEB GLUTEN RELIEF HNS UT 11-216 N VEGPANZYME 1213 VEGPANZYME 1X VEGPANZYME PLUS VT 11-693
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
13,685 kg
Product Codes / Lot Numbers
Lot Numbers: 3071056 3051069 3061036 3041059; 3061050 3061040 3071014; 3071015 3061044 3051009 3051042 3061058 3041089 3031082 3041038 3041024 3061043 3051040 3061062 3031029; 3061047; 3061048; 3041030 3031050; 3031080; 3031081 3071002 3041013; 3051091 3041037; 3041054 3031028; 3041031 3041073 3041025; 3041026; 3041027; 3061060 3081004 3031034 3031055 3041007 3071045; 3061034 3031066 3051043; 3071006 3051007 3041056; 3061026 3031053 3041064 3051050; 3051056 3031049; 3041034 3061054 3071025; 3071026 3041084 3071012
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.