Bio-Cat Recalls Xylanase Enzyme Blends Due to Chloramphenicol Contamination
Bio-Cat Inc is recalling bulk xylanase enzyme blends intended for food and dietary supplement manufacturing due to potential chloramphenicol contamination.
The agency’s classification
FDA (Food): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric. The presence of chloramphenicol, a prohibited antibiotic in food, represents a significant health hazard.
Plain-English summary
Bio-Cat Inc is voluntarily recalling 3,276 kg of bulk xylanase enzyme blends and custom blended formulations. The products, which include various xylanase, cellulase, and multi-enzyme blends, are raw materials intended for the further manufacturing of foods and dietary supplements. The recall is being conducted because the products may be contaminated with chloramphenicol.
The affected products were distributed to manufacturers and distributors nationwide and to Canada. The products are packed in boxes or drums ranging from 1 kg to 25 kg and are labeled with the manufacturer's information. Specific lot numbers are listed in the official recall notice.
Consumers who have purchased these products should stop using them and contact Bio-Cat Inc for further instructions. Because these are raw materials intended for industrial manufacturing, the primary risk is to the final food or dietary supplement products that may have been produced using these contaminated enzymes.
The recalled product
- Product
- Xylanase Enzyme Blends, bulk, custom blended formulations identified as xylanase 1000, xylanase 150,000 XU, synerzyme-ae, brizyme, Cellulase Special Blend OMRI, xylanase amylase blend, Bio-Cat Ruminant Enzyme, Feed Blend ws alkacel 20x, BC-XR, enzyme blend #2237, CHX blend…
- Manufacturer
- Bio-Cat Inc
- Category
- Food — Raw Materials / Enzymes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Bio-Cat Inc 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 3 products in this recall →Related recalls
Same manufacturer · Bio-Cat Inc
See all →- ModerateBio-Cat Recalls Cellulase Enzyme Blends Due to Chloramphenicol Contamination
FDA (Food) · 2013-11-27
- SevereBio-Cat Recalls Pectinase Enzyme Blends Due to Chloramphenicol Contamination
FDA (Food) · 2013-11-27
Same hazard · chloramphenicol contamination
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