Vi-Jon, LLC Expands Nationwide Voluntary Recall of All Flavors and Lots Prior to Expiry Date of Magnesium Citrate Saline Laxative Solution Due to Microbial Contamination

Summary

company announcement

FOR IMMEDIATE RELEASE – July 25, 2022 – Smyrna, TN, Vi-Jon, LLC is expanding its voluntary recall to include all lots of all flavors of Magnesium Citrate Saline Laxative through the expiration date to the consumer level. This expansion includes all 10 FL OZ (296ml) lots of Magnesium Citrate Cherry Flavored and Grape Flavored Saline Oral Laxative Solution prior to the expiration date. On July 14, 2022, Vi-Jon, LLC recalled all lots of Oral Saline Laxative Solution Magnesium Citrate, Lemon Flavor, 10 FL OZ (296 ml) prior to the expiration date. The recall was initiated after third party microbial testing by Vi-Jon, LLC identified the presence of Gluconacetobacter liquefaciens.

Risk Statement: Immunocompromised patients consuming this product may be at increased risk of invasive infections caused by Gluconacetobacter liquefaciens which could have serious and life-threatening adverse health consequences. At this time, Vi-Jon, LLC is aware of 3 (three) reports of serious adverse reactions potentially related to this recall. Vi-Jon, LLC is investigating these reports.
The product is used for the relief of occasional constipation (irregularity) and generally produces a bowel movement in ½ to 6 hours. The product is packaged in a 10 oz clear round plastic bottle.

In addition to lemon flavor, the recall now includes cherry flavor and grape flavor listed below in the table in bold.

The product was distributed nationwide to wholesale and retail outlets. Vi-Jon, LLC is continuing to investigate the cause of the issue.

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

Consumers with questions regarding this recall may contact Vi-Jon, LLC via email ([email protected]) Monday through Friday, 7:30 a.m. to 4:30 p.m. Central Time. Consumers should contact their doctor or health care provider if they have experienced any problems that may be related to taking or using this pharmaceutical product. www.vijon.com

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 the form or call 1-800-332-1088 to request a reporting form, then complete and return it to the address on the pre-addressed form, or submit it by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the United States Food and Drug Administration.

Link to the 3rd expansion press release

Link to the press release of the 1st expansion

Link to original press release