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Feb 09, 2024

VI

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the

COMPANY ANNOUNCEMENT

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Vi-Jon, LLC is revising a previously reported list of all flavors of Magnesium Citrate Saline Laxative Oral Solution within expiry that were voluntarily recalled to the consumer level to include product that was distributed in the United States, Canada and Panama. This 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 recall was initiated after Vi-Jon, LLCs third party microbial testing identified the presence of Gluconacetobacter liquefaciens.

Risk Statement: 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. To date, Vi-Jon, LLC is aware of 3 (three) reports of serious adverse reactions potentially related to this recall. Vi-Jon, LLC is in the process of investigating these reports.

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 includes the Cherry flavor and Grape flavor noted below in the table.

August 3, 2022 - The Recall product list has been updated to include the products noted below in Bold print.

The product was distributed in the United States, Canada and Panama to wholesale and retail outlets. Vi-Jon, LLC is continuing their investigation into the cause of the problem.

Vi-Jon, LLC is notifying its customers by phone and email and is arranging for return or destruction of all recalled product. Consumers that have this recalled product should stop using and return any remaining product to the place of purchase.

Consumers with questions regarding this recall can contact Vi-Jon, LLC by e-mail ([email protected]) or phone call (615) 208-2441, Monday-Friday, from 7:30 am to 4:30 pm, Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. www.vijon.com

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Link to 2nd Expansion Press ReleaseLink to 1st Expansion Press ReleaseLink to Initial Press Release

08/04/2022

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