FDA MedWatch - CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor by Vi-Jon
U.S. Food and Drug Administration sent this bulletin at 06/24/2022 08:02 AM EDT
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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
TOPIC: CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor by Vi-Jon: Recall - Due to Microbial Contamination
AUDIENCE: Consumer, Health Professional, Pharmacy, Gastroenterology
ISSUE: Vi-Jon is recalling one lot, 0556808, of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) because testing identified the affected lot of the product to contain the bacteria 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 not received any complaints 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 1/2 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.
Consumers and health professionals 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: