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Safety Report: Vi-Jon, LLC Magnesium Citrate Saline Laxative Oral Solution - recalled due to bacterial contamination, USA
2 years ago •source fda.gov
Recall notice
United States
Smyrna, TN, Vi-Jon, LLC is expanding its voluntary recall to include all lots of all flavors of Magnesium Citrate Saline Laxative Oral Solution within expiry to the consumer level. This expansion includes all lots of Cherry Flavor and Grape Flavor of Magnesium Citrate Saline Laxative Oral Solution, 10 FL OZ (296 mL) within expiry. On July 14, 2022, Vi-Jon, LLC recalled all lots of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) within expiry. The product was distributed Nationwide to wholesale and retail outlets. To date, Vi-Jon, LLC is aware of 3 (three) reports of serious adverse reactions potentially related to this recall.Immunocompromised patients, who consume this product, may be at increased risk for invasive infections caused by Gluconacetobacter liquefaciens that could lead to serious, life-threatening adverse health consequences. The recall was initiated after Vi-Jon, LLCs third party microbial testing identified the presence of Gluconacetobacter liquefaciens. Vi-Jon, LLC is continuing their investigation into the cause of the problem.
The product is used for relief of occasional constipation (irregularity) and generally produces bowel movement in ½ to 6 hours. The product is packaged in a 10 oz clear round plastic bottle. In addition to the lemon flavor, the recall now includes the Cherry flavor and Grape flavor noted below in the table in bold print. Affected Brand, NDC #, UPC # information are listed in the link below.
In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.
Company name: Vi-Jon, LLC
Brand name: Multiple Brands
Product recalled: Magnesium Citrate Saline Laxative Oral Solution
Reason of the recall: Potential Gluconacetobacter liquefaciens contamination
FDA Recall date: July 26, 2022
Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vi-jon-llc-expands-voluntary-nationwide-recall-all-flavors-and-lots-within-expiry-magnesium-citrate
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