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

U.S. Food and Drug Administration sent this bulletin at 07/19/2022 09:45 AM EDT

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor by Vi-Jon: Recall - Due to Microbial Contamination

AUDIENCE: Consumer, Patient, Health Professional, Pharmacy

ISSUE: Vi-Jon is expanding its recall to include all lots of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL). The recall was initiated after 3rd Party and Vi-Jon 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 has received one report of an adverse reaction potentially related to this recall.

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 that have this recalled product should stop using and return any remaining product to the place of purchase.

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.
Consumers with questions regarding this recall can contact the company.

Health professionals and consumers 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.

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