Mira Health Recalls Biogenix USA Formex Capsules Due to Contamination Risk
Mira Health Products Ltd. is recalling Biogenix USA Formex capsules because they may contain undeclared steroids or chemical additives due to poor manufacturing practices.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of harm from undeclared steroids and pharmaceutical ingredients in a dietary supplement, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Mira Health Products Ltd. is voluntarily recalling Biogenix USA Formex capsules. The product is 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).
The recall includes all lots of the product that are within their expiration date and were distributed prior to August 2013. The product was distributed in Georgia, Florida, and North Carolina, and possibly in New Jersey and New Zealand.
Consumers who have purchased this product should stop using it and contact the recalling firm for instructions on how to return it or dispose of it safely.
The recalled product
- Product
- Biogenix USA Formex 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.
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