FDA recall record

Specialty Enzymes & Biotechnologies Cellulase & Protease: APEX 10-639 A DIGESEB DIGESEB PLUS recall — FDA F-0135-2014

Specialty Enzymes and Biotechnologies is recalling cellulase/mannanase and fungal protease because they may contain low levels of chloramphenicol.

Class IIclassification
F-0135-2014official record ID
Nov 20, 2013report date

Recall record at a glance

Official recordF-0135-2014
CategoryFood Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmSpecialty Enzymes & Biotechnologies
Report dateNov 20, 2013
Recall initiation dateOct 3, 2013
Quantity13,685 kg
LocationChino, CA, United States

Official 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

Why the product was recalled

Specialty Enzymes and Biotechnologies is recalling cellulase/mannanase and fungal protease because they may contain low levels of chloramphenicol.

Distribution information

Nationwide in US and worldwide to: Australia, Canada, Malaysia, Taiwan, Italy

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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