Allergy Research Group Sugar Balance Formula Recalled for Chloramphenicol Contamination
Allergy Research Group is recalling Sugar Balance Formula dietary supplements because raw material cellulase enzymes were found to be contaminated with Chloramphenicol.
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. According to the rubric, an FDA Class II recall with significant injury or property damage reports, or in this case, a significant contamination hazard (Chloramphenicol), warrants a score of 4 (Severe).
Plain-English summary
Allergy Research Group is voluntarily recalling Sugar Balance Formula, a hypoallergenic dietary supplement containing 90 vegetarian capsules. The recall was initiated after the firm was notified by its contract manufacturer that the raw material supplier had issued a voluntary recall. The raw material supplier determined that certain cellulase enzymes used in the product were contaminated with Chloramphenicol.
The affected product is identified by Product number 75660, Lot number 0613057, and an expiration date of August 2015. A total of 182 bottles were distributed. The product was sold in Illinois, Florida, Georgia, Nevada, New York, California, New Hampshire, Arizona, Switzerland, and New Zealand.
Consumers who have purchased this product should stop using it and contact the manufacturer for further instructions. The recall is being conducted to remove the contaminated product from the market.
The recalled product
- Product
- Allergy Research Group Sugar Balance Formula, dietary Supplement, Hypoallergenic, 90 vegetarian capsules. Formulated exclusively for: Allergy Research Group; Alameda, CA 94502.
- Manufacturer
- Allergy Research Group
- 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 (3)
- Product number 75660
- Lot number 0613057
- Expiration: August 2015.
Distribution
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