National Enzyme Recalls Bulk Digest Powder Due to Chloramphenicol
National Enzyme Co is recalling 3989 Bulk TPP TEC DIGEST powder because it may contain chloramphenicol levels exceeding 0.3 ppb.
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 prohibited antibiotic contaminant.
Plain-English summary
National Enzyme Co is voluntarily recalling 3989 Bulk TPP TEC DIGEST powder, SKU 81814. The product is a dietary supplement raw material packaged in poly bags within corrugated containers. The recall involves 103.14 kg of product from lots 81814110 and 81814111.
The recall is being conducted because the raw material may contain chloramphenicol at levels greater than 0.3 ppb. Chloramphenicol is an antibiotic that is not permitted in food or dietary supplements in the United States.
The product was distributed domestically to direct accounts in 27 states across all geographical regions. It was also distributed to direct accounts in Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom. Consumers and businesses should stop using the product and contact the recalling firm for instructions on disposal or return.
The recalled product
- Product
- 3989 Bulk TPP TEC DIGEST powder, Transformation Enzyme Corporat, packaged in varying quantities in poly bags within corrugated containers. SKU 81814
- Manufacturer
- National Enzyme Co
- Category
- Food — Dietary Supplement
- Hazard
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#: 81814110 and 81814111
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 81 recalled by National Enzyme Co 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.
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