Mira Health Products Recalls Biogenix USA Serenity Capsules for Potential Contamination
Mira Health Products Ltd. is recalling Biogenix USA Serenity capsules due to potential contamination with undeclared steroids, pharmaceutical ingredients, or chemical additives.
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' rating under the rubric, particularly given the potential for undeclared pharmaceutical ingredients and steroids.
Plain-English summary
Mira Health Products Ltd. is recalling Biogenix USA Serenity 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 due to a lack of Good Manufacturing Practices (GMPs).
The affected product includes all lots within their expiry dates that were distributed prior to August 2013. The product was distributed in Georgia, Florida, North Carolina, and possibly New Jersey and New Zealand.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- Biogenix USA Serenity 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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