Mira Health Products Recalls Biogenix USA Tendex Capsules Due to Contamination Risk
Mira Health Products Ltd. is recalling Biogenix USA Tendex capsules because they may contain undeclared steroids or chemical additives due to poor manufacturing practices.
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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe).
Plain-English summary
Mira Health Products Ltd. is recalling Biogenix USA Tendex capsules, which are packaged as a bulk product in clear plastic bags. The recall is being conducted because the dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients, and/or chemical additives. This risk exists due to a lack of Good Manufacturing Practices (GMPs) during production.
The affected products include all lots that are within their expiry date and were distributed prior to August 2013. The source text indicates that these products were distributed in Georgia, Florida, North Carolina, and possibly New Jersey and New Zealand.
Consumers who have purchased these products should stop using them and contact the recalling firm for further instructions or a refund. 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.
The recalled product
- Product
- Biogenix USA Tendex capsules, packaged as a bulk product in clear plastic bags.
- Manufacturer
- Mira Health Products Ltd.
- 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 (1)
- All lots within expiry and distributed prior to August 2013
Distribution
Part of a larger recall action
This product is one of 79 recalled by Mira Health Products Ltd. 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 79 products in this recall →Related recalls
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