Mira Health Recalls L-Carnitine Supplements for Potential Steroid Contamination
Mira Health Products Ltd. is recalling L-Carnitine supplements due to potential contamination with undeclared steroids and chemical additives caused by a lack of Good 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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or structural defects are rated as Severe (4).
Plain-English summary
Mira Health Products Ltd. is recalling L-Carnitine dietary supplements labeled in part as "Healthy Life Chemistry" by Purity First. The products are packaged in white bottles containing 90 capsules with black font and a Ying & Yang symbol. The supplements were manufactured for Purity First Health Products, Inc. and distributed in Georgia, Florida, North Carolina, and possibly New Jersey and New Zealand.
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 the production process. The recall includes all lots within expiry that were distributed prior to August 2013.
Consumers who have purchased these products should stop using them and contact the recalling firm for further instructions. 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
- L-Carnitine, labeled in part as "Healthy Life Chemistry" By Purity First, Est. 1991, packaged in white bottles (90 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street…
- 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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