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  4. Vi-Jon, LLC Expands Voluntary Nationwide Recall of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination
  1. Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT

Vi-Jon, LLC Expands Voluntary Nationwide Recall of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Recall Reason Description
Microbial contamination with Gluconacetobacter liquefaciens
Company Name:
Vi-Jon, LLC
Brand Name:
Brand Name(s)
Multiple brand names
Product Description:
Product Description
Magnesium Citrate Saline Laxative Oral Solution, Lemon Flavor

Company Announcement

July 14, 2022 – Smyrna, TN, Vi-Jon, LLC is expanding its voluntary recall to include all lots of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) within expiry to the consumer level.  The recall was initiated after 3rd Party and Vi-Jon, LLC microbial testing identified the presence of 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 received one report of an adverse reaction potentially related to this recall.  Vi-Jon, LLC is in the process of investigating this report.

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 affected brands of Magnesium Citrate Laxative Oral Solution Lemon Flavor manufactured at Vi-Jon, LLC in Smyrna, TN are:

Affected Brand

NDC #

UPC #

BEST CHOICE 10OZ LEMON MAG CIT 63941-533-38 070038200499
CARE ONE 10OZ LEMON MAG CIT 72476-001-38 341520313226
CARIBA 10OZ LEMON MAG CITRATE 67860-166-38 646702057012
CRUZ BLANC 10OZ LEMON MAG CIT N/A 308697403082
CVS 10OZ LEMON MAG CIT 63868-929-38 050428335178
CVS 10OZ LEMON MAG CIT 69842-983-38 050428305942
DISCOUNT DRUG MART 10OZ LEMON MAG CITRATE 53943-166-38 093351028205
EQUALINE 10OZ LEMON MAG CIT 41163-709-38 041163500679
EQUATE 10OZ LEMON MAG CIT SRP 49035-506-38 681131287142
EXCHANGE SELECT 10OZ LEMON MAG CIT 55301-166-38 614299404205
FAMILY WELLNESS 10OZ LEMON CITRATE 55319-666-38 032251580826
GOOD SENSE 10OZ LEMON MAG CIT 50804-166-38 846036007374
HARRIS TEETER 10OZ LEMON MAG CITRATE 72036-002-38 072036726124
HEB 10OZ LEMON MAG CITRATE 37808-769-38 041220510863
HEALTH MART 10OZ LEMON MAG CIT 62011-0380-1 052569142158
KROGER 10OZ LEMON MAG CITRATE 30142-899-38 041260001826
LEADER 10OZ LEMON MAG CIT 70000-0424-1 096295135541
MAJOR 10OZ LEMON MAG CITRATE 0904-6787-44 309046787440
MEIJER 10OZ LEMON MAG CIT 41250-708-38 713733459457
PREMIER VALUE 10OZ LOW SOD LEM CIT 68016-696-38 840986035302
PUBLIX 10OZ LEMON MAG CIT 56062-266-38 041415506732
QUALITY CHOICE 10OZ LEMON MAG CIT 63868-929-38 635515901254
REXALL 10OZ LEMON MAG CITRATE 55910-183-38 072785134188
RITE AID 10OZ LEMON CITRATE 11822-4330-2 011822433006
SIGNATURE CARE 10OZ LEMON MAG CIT 21130-709-38 321130779155
SOUND BODY 10OZ LEMON MAG CIT 50594-166-38 072785114791
SUNMARK 10OZ LEMON MAG CIT 70677-0051-1 010939908445
SWAN 10OZ LEMON MAG CITRATE 0869-0166-38 072785134058
TOPCARE 10OZ LEMON MAG CITRATE 36800-709-38 036800455290
UP&UP 10OZ LEMON MAG CIT 11673-708-38 072785128835
UP&UP 10OZ LEMON MAG CIT 11673-666-38 072785128835
WALGREENS 10OZ LEMON MAG CIT 0363-8166-38 311917201603

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.

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.

Link to 3rd Expanded Release

Link to Initial Press Release

Link to 2nd Expanded Release

Company Contact Information

Consumers:
Vi-Jon, LLC
Recalls@Vijon.com
Media:
Mr. Joseph Meehan, Chief Sales and Marketing Officer
615-208-2441

Product Photos

  • Image 1 - Representative labeling, Magnesium Citrate Saline Laxative Oral Solution, Lemon Flavor
  • Image 2 - Representative labeling, Magnesium Citrate Saline Laxative Oral Solution, Lemon Flavor
  • Image 3 - Representative labeling, Magnesium Citrate Saline Laxative Oral Solution, Lemon Flavor
  • Image 4 - Representative labeling, Magnesium Citrate Saline Laxative Oral Solution, Lemon Flavor
  • Image 5 - Representative labeling, Magnesium Citrate Saline Laxative Oral Solution, Lemon Flavor
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