Smyrna, Tennessee-based Vi-Jon, LLC has expanded the recall of Magnesium Citrate Saline Laxative Oral Solution to now include all flavors and all lots within expiry to the consumer level due to microbial contamination, the U.S. Food and Drug Administration said.
The product is used for relief of occasional constipation, irregularity, and generally produces bowel movement in 1/2 to 6 hours.
Vi-Jon earlier had called back all lots of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) within expiry.
The recall expansion includes all lots of Cherry Flavor and Grape Flavor of Magnesium Citrate Saline Laxative Oral Solution, 10 FL OZ (296 mL) within expiry.
The affected product comes under various brands such as Best Choice, Care One, Cariba, Cruz Blanc,CVS, Discount Drug Mart, Equaline, Equate, Family Wellness, HEB, Health Mart, Kroger, Meijer, Rite Aid, and Walgreens, among others.
The product is packaged in a 10 oz clear round plastic bottle, and distributed Nationwide to wholesale and retail outlets.
The recall was initiated after Vi-Jon's third party microbial testing identified the presence of Gluconacetobacter liquefaciens.
The agency noted that 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.
Vi-Jon received 3 reports of serious adverse reactions potentially related to the recall to date. The company is in the process of investigating these reports.
Consumers are urged to stop using the product and return any remaining product to the place of purchase.
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