Park Labs Reparagen Pro Recalled for Potential Steroid Contamination
Mira Health Products Ltd. is recalling Park Labs Reparagen Pro capsules due to potential contamination with undeclared steroids and pharmaceutical ingredients.
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 agency classification is FDA Class II, and the hazard involves potential contamination with undeclared steroids and pharmaceutical ingredients, which aligns with the criteria for a Severe rating.
Plain-English summary
Mira Health Products Ltd. is recalling Park Labs Reparagen Pro capsules, which are packaged in plastic bottles containing 60 capsules each. 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 recall includes all lots of the product that are within their expiration date and were distributed prior to August 2013. The affected products were distributed in Georgia, Florida, and North Carolina, and possibly in New Jersey and New Zealand.
Consumers who have purchased these capsules should stop using them immediately. They should return the product to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- Park Labs Reparagen Pro capsules packaged in a plastic bottle with 60 capsules per bottle.
- 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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