The Recall Desk
ModerateFDA (Food)·F-0133-2014·Announced 2013-11-20

Specialty Enzymes Recalls Cellulase Products Due to Chloramphenicol Contamination

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

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text specifies 'low levels' of contamination without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Specialty Enzymes and Biotechnologies is voluntarily recalling specific lots of cellulase/mannanase and fungal protease products. The recall is being conducted because the products may contain low levels of chloramphenicol.

The affected products include various cellulase brands and formulations, such as ACTA, APEX, ARTH, BETA GLUCANASE, BROOK, CELLULASE, CENTURY, CLENZSEB, DIGESEB, EB, EL, GLOBAL, GREENZYME, HEMISEB, JARL, NAT, NF, NHK, NPC, NW, PB, SEB GLUTEN RELIEF, SUPER, TUMMYEASE, VEGPANZYME PLUS, and VR. The total quantity involved in the recall is 33,247.5 kg.

The products were distributed nationwide in the United States and internationally to Australia, Canada, Malaysia, Taiwan, and Italy. Consumers and businesses should check their inventory for the specific lot numbers listed in the official recall notice and discontinue use if they match the affected lots.

The recalled product

Product
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 1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Specialty Enzymes & Biotechnologies under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →