Vi-Jon, LLC Expands Voluntary Nationwide Recall of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination

Summary

Company Announcement

July 14, 2022 – Smyrna, TN, Vi-Jon, LLC is expanding its voluntary recall to include all lots of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) within expiry to the consumer level.  The recall was initiated after 3rd Party and Vi-Jon, LLC 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 has received one report of an adverse reaction potentially related to this recall.  Vi-Jon, LLC is in the process of investigating this report.

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.

The affected brands of Magnesium Citrate Laxative Oral Solution Lemon Flavor manufactured at Vi-Jon, LLC in Smyrna, TN are:

The product was distributed Nationwide 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]) 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.

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.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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

Link to Initial Press Release