Pro Thera Dual Detox Dietary Supplement Recalled for Chloramphenicol Contamination
ProThera, Inc. is recalling Pro Thera Dual Detox Dietary Supplement because the enzyme Xylanase ingredient was found to be contaminated with 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant health risks.
Plain-English summary
ProThera, Inc. is recalling Pro Thera Dual Detox Dietary Supplement, 60 capsules, manufactured in Reno, Nevada. The recall involves Lot B3222, product code DTX. The firm was notified by its supplier that the enzyme Xylanase used in the product was contaminated with chloramphenicol.
The affected product was distributed in the United States, Canada, Germany, Great Britain, Hong Kong, Malaysia, Mexico, the Philippines, Russia, Singapore, South Korea, and Spain. The total quantity involved is 54,503 capsules.
Consumers who have purchased this product should stop using it and contact ProThera, Inc. for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Pro Thera Dual Detox Dietary Supplement; 60 capsules; Chlorella - 500 mg; Broccoli Sprout, dried extract - 60 mg; Enzyme Blend - supplying Beta-Glucanase, Cellulase, Protease, Hemicellulase, Phytase and Xylanase Manufactured by ProThera, Reno, NV,
- Manufacturer
- ProThera, Inc.
- Category
- Food — Dietary Supplement
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 (2)
- Lot B3222
- product code DTX
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by ProThera, 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.
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