Vi-Jon, LLC is expanding its initial recall of all flavors and lots of Magnesium Citrate Saline Laxative Oral Solution within expiry due to microbial contamination. The consumer-level recall now includes products distributed in the United States, Canada, and Panama.
All Cherry Flavor and Grape Flavor of Magnesium Citrate Saline Laxative Oral Solution lots within expiry are now included in this recall.
Vi-Jon has initiated this recall after third-party testing revealed the presence of microbial contamination (Gluconacetobacter liquefaciens) in some finished product lots.
This potential contaminant poses a risk to consumers if ingested, and Vi-Jon is taking this action out of an abundance of caution.
Immunocompromised patients who consume this product may be at an increased risk of invasive infections due to the presence of Gluconacetobacter liquefaciens. This could lead to life-threatening consequences.
To date, Vi-Jon has received up to three (3) reports of adverse events related to this recall and is in the process of investigations.
This product is indicated for relief of occasional constipation and softening of stool for easier passage and works within ½ to 6 hours. The product is sold over-the-counter (OTC) and is packaged in a 10 oz clear round plastic bottle.
These products were distributed to retailers and distributors nationwide in the United States, Canada, and Panama. Vi-Jon is currently carrying out investigations into the cause of the issue. They are also notifying consumers by phone of the recall and are asking anyone who has purchased these products to return them to their place of purchase.
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In addition to the Lemon Flavor indicated in the first expansion press release, the new recall now includes Cherry flavor and Grape flavors from different brands, as noted in this second expansion press release.
The additional products included in the recall are as follows:
|CANADA||NPN #||UPC #|
|Equate Canada 300 mL Lemon Magnesium Citrate||NPN 80015316||079068004923|
|Life 300 mL Lemon Magnesium Citrat||NPN 80015316||057800856412|
|Life 300 mL Cherry Magnesium Citrate||NPN 80015316||057800856405|
|Personnelle 300 mL Lemon Citrate||NPN 80015316||055989029306|
|Panama||NDC #||UPC #|
|CRUZ BLANC 10OZ LEMON MAG CIT||N/A||308697403082|
What To Do
Consumers who have purchased the affected products should stop using them immediately and return them to the place of purchase for a refund.
You can also contact Vi-Jon at (615) 208-2441, Monday-Friday, from 7:30 am to 4:30 pm, Central Time, or send an email to [email protected].
Consumers who have experienced any problems related to the use of this product should also contact their healthcare providers immediately.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Fax: 1-800-FDA-0178
This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA)