Vi-Jon Recalls Magnesium Citrate Oral Solution Due to Mold Contamination
Vi-Jon, Inc. is recalling 101,244 bottles of Magnesium Citrate Oral Solution because the product was found to contain mold identified as Rhinocladiella similis.
The agency’s classification
FDA (Drugs): 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. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant contamination like mold in a non-sterile product.
Plain-English summary
Vi-Jon, Inc. is recalling 101,244 bottles of Magnesium Citrate Oral Solution, packaged in 10 fl. oz. (296 mL) glass bottles. The recall affects multiple private-label brands, including GoodSense, Premier Value, Swan, and ShopRite, which are distributed by various companies in Georgia, Pennsylvania, and New Jersey.
The recall was initiated because the non-sterile product was found to contain microbial contamination, specifically mold identified as Rhinocladiella similis. The affected lots include 0341906 with an expiration date of 12/2018 and lot 0343709 with an expiration date of 1/2019.
Consumers who have purchased these products should stop using them and return them to the place of purchase for a refund. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Magnesium Citrate Oral Solution, packaged in a 10 fl. oz. (296 mL) glass bottle, OTC, labeled as: a) GoodSense Magnesium Citrate Oral Solution Saline Laxative Very Low Sodium, UPC# 846036007381, NDC 50804-686-38, Distributed by: Geiss, Desitin &Dunn, Inc., Peachtree City, GA…
- Manufacturer
- Vi-Jon, Inc.
- Affected units
- 101,244
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 (6)
- Lot#: a) 0341906
- Exp 12/2018
- b) 0341906 Exp 12/2018
- c) 0341906
- 0343709
- Exp 1/2019 d) 0343709 Exp 1/2019
Distribution
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