Specialty Enzymes Recalls Papain and Enzymes Due to Chloramphenicol Contamination
Specialty Enzymes & Biotechnologies is recalling specific lots of papain and fungal enzymes because they may contain low levels of 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 FDA has classified this recall as Class II. According to the severity rubric, an FDA Class II recall corresponds to a severity score of 4 (Severe), as the agency's own classification mandates a minimum score of 4.
Plain-English summary
Specialty Enzymes & Biotechnologies is voluntarily recalling specific lots of papain, cellulase/mannanase, and fungal protease. The recall is being conducted because the products may contain low levels of chloramphenicol.
The affected products include Papain NF 4-608 B, NF 4-6152, NUTRA 6-452, PAPAIN PROHYDROXY NF 4-714, cellulase/mannanase, and fungal protease. The total quantity involved is 625 kg. The specific lot numbers affected are 3061056, 3071003, 3071021, 3070018, and 3061057.
These products were distributed nationwide in the United States and internationally to Australia, Canada, Malaysia, Taiwan, and Italy. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Papain: NF 4-608 B NF 4-6152 NUTRA 6-452 PAPAIN PROHYDROXY NF 4-714
- Manufacturer
- Specialty Enzymes & Biotechnologies
- Category
- Food — Food Ingredients
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 (1)
- Lot Numbers: 3061056 3071003 3071021 3070018 3061057
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 →Related recalls
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