Smyrna, TN, Vi-Jon, LLC expands its voluntary recall of all flavors and lots within the expiry of magnesium citrate saline laxative oral solution because of microbial contamination.
The recall affects the Magnesium Citrate Saline Laxative Oral Solution of Cherry Flavor and Grape Flavor. The affected products are 10 FL OZ (296 mL) within expiry.
The recall happened after Vi-Jon, LLC’s third-party microbial testing discovered the presence of Gluconacetobacter liquefaciens.
Risk Statement
The presence of Gluconacetobacter liquefaciens can cause invasive infections in Immunocompromised patients who consume the product. The infections can lead to potentially life-threatening complications. To date, Vi-Jon has received up to three (3) reports of serious adverse reactions potentially related to the consumption of the products and is in the process of investigation.
Magnesium Citrate Saline Laxative Oral Solution relieves occasional constipation and initiates bowel movement in ½ to 6 hours. This product is available over the counter without a prescription. The product is packaged in a 10 oz clear round plastic bottle.
The affected product was distributed nationwide in the United States to major retailers and wholesalers. Vi-Jon, LLC is currently investigating the possible cause of the issue and has notified the customers who may have received the affected product.
While the initial recall only affected lemon flavor, the new recall now includes Cherry flavor and Grape flavor with different brands and NDC numbers.
Actions Taken
Vi-Jon is contacting its customers by mail and phone and arranging the return of the affected products. Consumers who have recently purchased any of the products listed above should not consume them and return the product to the place of purchase.
Consumers with questions regarding the recall should contact Vi-Jon, Monday through Friday, from 8:00 a.m. to 5:00 p.m. CDT at 1-800-321-1345 or by email at [email protected].
Consumers are also urged to talk to their physicians and healthcare providers if they experience any problems related to using the recalled products.
Report any adverse reactions to quality issues through the FDA’s MedWatch Adverse Event Reporting Program at www.fda.gov/medwatch or by calling 1-800-332-1088. You can also submit the report submit by fax to 1-800-FDA-0178.
