Bairn Biologics Candisol Recalled Due to Chloramphenicol Contamination
Bairn Biologics is recalling Candisol dietary supplements because the xylanase enzyme ingredient was 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, which corresponds to a Severe severity score under the rubric, particularly given the presence of a significant contaminant like Chloramphenicol.
Plain-English summary
Bairn Biologics is recalling Candisol, a dietary supplement marketed as natural enzymes to support a healthy gastrointestinal tract. The recall was initiated after the firm was notified by its supplier that the xylanase enzymes used in the product were contaminated with Chloramphenicol.
The affected product is packaged in 40 and 120 count amber glass bottles. The recall includes all lots manufactured from 2009 forward, with expiry dates ranging from March 2011 through May 2015. The total quantity involved is 8,232 bottles of the 40-count size and 27,882 bottles of the 120-count size.
The product was distributed in the United States, Australia, Guatemala, the United Kingdom, Israel, Canada, and Japan. Consumers should stop using the product and contact the manufacturer for further instructions.
The recalled product
- Product
- Bairn Biologics Candisol; Natural Enzymes to Support a Health Gastrointestinal Tract. Dietary Supplement; Ingredients: Vegetarian Cellulase, Vegetarian Hemicellulase, Vegetarian Xylanase, Vegetarian Beta-glucanase, microcrystalline Cellulose, L-Leucine, Vegetable Capsule.…
- Manufacturer
- Bairn Biologics
- 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 (2)
- all lots manufactured from 2009 forward
- Expiry dates: March 2011 through May 2015.
Distribution
Distribution scope not specified by the agency.
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