National Enzyme Recalls Digestenzyl Capsules Due to Chloramphenicol Contamination
National Enzyme Co is recalling bulk Digestenzyl capsules because they 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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant regulatory concerns like prohibited antibiotic residues.
Plain-English summary
National Enzyme Co is recalling 106,847 bulk Digestenzyl capsules (SKU 92033, Lot # 92033003). The product is packaged in poly bags within corrugated boxes for domestic distribution or fiber drums for international distribution.
The recall was initiated because the dietary supplements contain a raw material that may contain more than 0.3 ppb of chloramphenicol. The FDA has classified this recall as Class II, indicating a situation that may cause temporary or medically reversible adverse health consequences.
The product was distributed nationwide in the United States with direct accounts in 27 states across all geographical regions. It was also distributed internationally to direct accounts in Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom. Consumers should stop using the product and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Bulk 9399 OceanwideUSA DIGESTENZY capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92033);
- Manufacturer
- National Enzyme Co
- Category
- Food — Dietary Supplement
- Affected units
- 106,847
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 #: 92033003
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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