Bio-Cat Recalls Pectinase Enzyme Blends Due to Chloramphenicol Contamination
Bio-Cat Inc is recalling bulk pectinase enzyme blends intended for food and dietary supplement manufacturing because they may be contaminated with chloramphenicol.
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, particularly given the presence of a significant contaminant like chloramphenicol.
Plain-English summary
Bio-Cat Inc is recalling bulk pectinase enzyme blends, including custom blended formulations such as pectinase 500, pectinase 1000, and PC Blend 14. These products are raw material enzymes intended for the further manufacturing of foods and dietary supplements. The recall is due to the potential contamination of these products with chloramphenicol.
The recalled products were packed in boxes or drums ranging from 1 kg to 25 kg and are labeled with the manufacturer's information. A total of 3,276 kg of these products were involved in the recall. The products were distributed to manufacturers and distributors nationwide and to Canada.
Consumers should note that these are raw material enzymes intended for industrial use in the manufacturing of other products, not for direct consumer consumption. Individuals who have purchased these products should stop using them and contact Bio-Cat Inc for further instructions.
The recalled product
- Product
- Pectinase Enzyme Blends, bulk, custom blended formulations identified as pectinase 500, pectinase 1000, Pectinase 350 Endo-pg/gm, PC Blend 14, Nut 14-500, pectinase 3500, gastro blend 0111, Digestive Blend 021894, enzyme complex 5763, pectinase 1750, pectinase 350, EC-CHPX…
- Manufacturer
- Bio-Cat Inc
- Category
- Food — Raw Material 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
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- SevereBio-Cat Recalls Xylanase Enzyme Blends Due to Chloramphenicol Contamination
FDA (Food) · 2013-11-27
Same hazard · chloramphenicol contamination
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