Safety Report: Magnesium Citrate Saline Laxative Oral Solution - recalled due to microbial contamination, USA

United States

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. 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.

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. 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.

On August 3, 2022, the Recall product list has been updated to include the products noted below.

CANADA Equate Canada 300 mL Lemon Magnesium Citrate
NPN # NPN 80015316
UPC # 079068004923

CANADA Life 300 mL Lemon Magnesium Citrat
NPN # NPN 80015316
UPC # 057800856412

CANADA Life 300 mL Cherry Magnesium Citrate
NPN # NPN 80015316
UPC # 057800856405

CANADA Personnelle 300 mL Lemon Citrate
NPN # NPN 80015316
UPC # 055989029306

PANAMA CRUZ BLANC 10OZ LEMON MAG CIT
NPN # N/A
UPC # 308697403082

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.

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

In case you experienced harm from these products, 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 brand names
Product recalled: Magnesium Citrate Saline Laxative Oral Solution
Reason of the recall: Microbial contamination with Gluconacetobacter liquefaciens
FDA Recall date: August 04, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vi-jon-llc-expands-voluntary-worldwide-recall-all-flavors-and-lots-within-expiry-magnesium-citrate