FDA MedWatch - Magnesium Citrate Saline Laxative Oral Solution by Vi-Jon

Recall Expansion - Due to Microbial Contamination

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Magnesium Citrate Saline Laxative Oral Solution by Vi-Jon: Recall Expansion - Due to Microbial Contamination AUDIENCE: Consumer, Patient, Health Professional, Pharmacy ISSUE: Vi-Jon, LLC is expanding its recall to include all lots of all flavors of Magnesium Citrate Saline Laxative Oral Solution. This expansion includes all lots of Cherry Flavor and Grape Flavor of Magnesium Citrate Saline Laxative Oral Solution within expiry. On July 14, 2022, Vi-Jon, LLC recalled all lots of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor because 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 three reports of serious adverse reactions potentially related to this recall. Vi-Jon, LLC is in the process of investigating these reports. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The product is used for relief of occasional constipation (irregularity) and generally produces bowel movement in ½ to 6 hours. RECOMMENDATIONS:  Consumers and patients that have this recalled product should stop using and return any remaining product to the place of purchase. Consumers and patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers, patients, and health professionals with questions regarding this recall can contact the company. Health professionals, consumers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178. Follow us on Twitter at @FDAMedWatch

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