U.S. Food and Drug Administration

Summary

Company Announcement

June 21, 2022 – Smyrna, TN, Vi-Jon, LLC is voluntarily recalling 1 (one) lot of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) to the consumer level. Testing identified the affected lot of the product to contain the bacteria Gluconacetobacter liquefaciens.

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 has not received any complaints related to this recall.

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The product is used for relief of occasional constipation (irregularity) and generally produces bowel movement in 1/2 to 6 hours. The product is packaged in a 10 oz clear round plastic bottle. The affected CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor lot includes the following batch number: 0556808 and expiration date: 12/2023 on the shoulder of the bottle. This lot of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor was sent to a 3rd Party Outside Lab for testing per CVS request as a first production sample for CVS. This lot of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor was distributed Nationwide at CVS drug store locations.

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Vi-Jon, LLC has already notified CVS by phone and email and is arranging for return 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.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

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

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