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Product Recall

Product Recall

Vi-Jon, LLC expands voluntary nationwide recall of Magnesium Citrate Saline Laxative Oral Solution

Vi-Jon, LLC expands voluntary nationwide recall of Magnesium Citrate Saline Laxative Oral Solution

 

Smyrna, TN, Vi-Jon, LLC is expanding its voluntary recall to include all lots of all flavors of Magnesium Citrate Saline Laxative Oral Solution within expiry to the consumer level. This expansion includes all lots of Cherry Flavor and Grape Flavor of Magnesium Citrate Saline Laxative Oral Solution, 10 FL OZ (296 mL) within expiry. On July 14, 2022, Vi-Jon, LLC recalled all lots of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) within expiry. The recall was initiated after Vi-Jon, LLCs third party microbial testing identified the presence of Gluconacetobacter liquefaciens.

In addition to the lemon flavor, the recall now includes the Cherry flavor and Grape flavor.

H-E-B has removed from stock all product impacted by this recall. Anyone with affected product is asked to throw away the impacted items or may return them to H-E-B for a full refund.

Product Name(s)  UPC Item Code Expiration/Sell By/Lot Numbers
H-E-B Magnesium Citrate Cherry 4122051087 594155 ALL
H-E-B Magnesium Citrate Grape 4122051088 419779 ALL
H-E-B Magnesium Citrate Lemon 4122051086 458389 ALL

This recall does not only affect H-E-B. This is a nationwide recall that affects multiple brands. For a full list of all product brands impacted by this nationwide recall, please refer to the official recall notice on the FDA’s website.

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, LLC is aware of 3 (three) reports of serious adverse reactions potentially related to this recall. Vi-Jon, LLC is in the process of investigating these reports.
The product is used for relief of occasional constipation (irregularity) and generally produces bowel movement in ½ to 6 hours. The product is packaged in a 10 oz clear round plastic bottle.

The product was distributed nationwide to wholesale and retail outlets. Vi-Jon, LLC is continuing their investigation into the cause of the problem.

Vi-Jon, LLC is notifying its customers by phone and email and is arranging for return or destruction of all recalled product. Consumers that have this recalled product should stop using and return any remaining product to the place of purchase.

Consumers with questions regarding this recall can contact Vi-Jon, LLC by e-mail (Recalls@Vijon.com) Monday-Friday, from 7:30 am to 4:30 pm, Central Time. 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.www.vijon.com External Link Disclaimer

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
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.