Laxative Recall Expanded Over Risk of Bacterial Infections

Following reports of bacterial infections associated with magnesium citrate laxative solutions, the manufacturer has expanded a prior recall to include all lots and flavors.

Vi-Jon, LLC initially issued the laxative recall in June, impacting lemon flavored products sold under more than 30 different store brand labels. However, in a statement posted by the FDA this week, the recall was expanded on July 25, impacting dozens of different flavors and product formulations.

The recalled laxatives now include cherry and grape flavors, as well as the lemon flavor originally recalled, including products sold under brand names like Best Choice, Care One, Chariba, CVS, Discount Drug Mart, Equaline, Equate, Exchange Select, Family Wellness, Good Sense, Harris Teeter, HEB, Health Mart, Kroger, Leader, Meijer, Premier Value, Publix, Quality Choice, Rexall, Rite Aid, Signature Care, Sunmark, Swan, Topcare, Up&Up and Walgreens.

Magnesium Citrate Saline Laxative Oral Solution is a product used to relieve occasional constipation and generally produces bowel movement in half an hour to six hours.

The laxative recall was first issued after third party testing identified the presence of Gluconacetobacter liquefaciens, a microbial contaminant. This is the second time the recall has been expanded. The original recall was limited to one lot of the product sold at CVS stores. Then the recall was expanded to include all lots of the lemon flavor, before this second expansion.

Consuming gluconacetobacter liquefaciens can increase a person’s risk of suffering bacterial infection. For patients who are immunocompromised, this can lead to serious, life-threatening adverse health consequences.

So far, at least three reports of serious adverse reactions have been linked to the recall. Vi-Jon is in the process of investigating those reports.

The products were packaged in a 10 oz clear round plastic bottle and sold in lemon, cherry and grape flavors, and distributed nationwide to wholesale and retail stores.

Vi-Jon is notifying its customers of the contamination and arranging for the return or destruction of all recalled products. Consumers who have the recalled product should stop using it immediately and return it to the place of purchase, even if there is some remaining product in the package.

Consumers can contact Vi-Jon with questions about the recall at Recalls@Vijon.com or by visiting their website at www.vijon.com.

Adverse reactions or side effects experienced from using the product should be reported to the FDA’s MedWatch Adverse Event Reporting program.