National Enzyme Recalls GLUTENEZYME Capsules Due to Chloramphenicol Contamination
National Enzyme Co is recalling GLUTENEZYME capsules because the raw material may contain chloramphenicol levels exceeding 0.3 ppb.
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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant contamination risks like chloramphenicol, even without explicit hospitalization reports in the provided text.
Plain-English summary
National Enzyme Co is recalling 835,013 bulk GLUTENEZYME capsules (SKU 92103) because the raw material used in the product may contain chloramphenicol at levels greater than 0.3 ppb. The affected product is packaged in poly bags within corrugated boxes for domestic distribution or fiber drums for international distribution.
The recall covers specific lot numbers: 92103002, 92103004, 92103005, 92103006, 92103007, and 92103008. The product was distributed nationwide to direct accounts in 27 states across all geographical regions. International distribution included direct accounts in Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.
Consumers and distributors should stop using the affected product and contact the recalling firm for instructions on return or disposal. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Bulk 9730 BIOSANLABS GLUTENEZYME capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92103).
- Manufacturer
- National Enzyme Co
- Category
- Food — Dietary Supplement
- Affected units
- 835,013
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 (6)
- Lot #'s: 92103002
- 92103004
- 92103005
- 92103006
- 92103007
- and 92103008
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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