The Recall Desk
SevereFDA (Food)·F-0177-2014·Announced 2013-11-27

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.

What this means for you

Illness, injury, or structural failure has been reported. 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, enzym
Manufacturer
Bio-Cat Inc

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 →