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

Original Post

Summary

Company Announcement Date: July 25, 2022

FDA Publish Date: July 26, 2022

Product Type: Drugs 

Reason for Announcement: Potential Gluconacetobacter liquefaciens contamination

Company Name: Vi-Jon, LLC

Brand Name: Multiple Brands

Product Description: Magnesium Citrate Saline Laxative Oral Solution

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 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.

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.

In addition to the lemon flavor, the recall now includes the Cherry flavor and Grape flavor noted below in the table in bold print. 

Affected Brand NDC # UPC # 
BEST CHOICE 10OZ LEMON MAG CITRATE63941-533-38070038200499
BEST CHOICE 10OZ CHERRY CITRATE63941-516-38 070038587903 
BEST CHOICE 10OZ GRAPE CITRATE63941-162-38 070038662204 
CARE ONE 10OZ LEMON MAG CIT72476-001-38341520313226
CARE ONE 10OZ CHERRY CIT72476-002-38 341520000553 
CARIBA 10OZ LEMON MAG CITRATE67860-166-38646702057012
CRUZ BLANC 10OZ LEMON MAG CITN/A308697403082
CVS 10OZ LEMON MAG CIT63868-929-38050428335178
CVS 10OZ LEMON MAG CIT69842-983-38050428305942
CVS 10OZ CHERRY CITRATE69842-647-38 050428297339 
CVS 10OZ CHERRY CITRATE69842-647-38 00050428285152 
CVS 10OZ CLR GRAPE CITRATE69842-763-38 050428307458 
CVS 10OZ CLR GRAPE CITRATE69842-763-38 00050428325032 
DISCOUNT DRUG MART 10OZ LEMON MAG CITRATE53943-166-38093351028205
EQUALINE 10OZ LEMON MAG CIT41163-709-38041163500679
EQUALINE 10OZ CHERRY CITRATE41163-769-38 041163500686 
EQUATE 10OZ LEMON MAG CIT SRP49035-506-38681131287142
EQUATE 10OZ CHERRY CIT SRP49035-593-38 681131287166 
EQUATE 10OZ GRAPE MAG CIT SRP49035-592-38 681131287159 
EXCHANGE SELECT 10OZ LEMON MAG CIT55301-166-38614299404205
FAMILY WELLNESS 10OZ LEMON CITRATE55319-666-38032251580826
FAM WELLNS 10OZ CHERRY CITRATE55319-164-38 032251577888 
GOOD SENSE 10OZ LEMON MAG CIT50804-166-38846036007374
GOOD SENSE 10OZ CHERRY CITRATE50804-164-38 846036007398
HARRIS TEETER 10OZ LEMON MAG CITRATE72036-002-38072036726124
HEB 10OZ LEMON MAG CITRATE37808-769-38041220510863
HEB 10OZ CHERRY CITRATE37808-673-38 00041220510870 
HEB 10OZ GRAPE MAG CITRATE37808-695-38 00041220510887 
HEALTH MART 10OZ LEMON MAG CIT62011-0380-1052569142158
HEALTH MART 10OZ CHERRY CIT62011-0381-1 052569142165 
KROGER 10OZ LEMON MAG CITRATE30142-899-38041260001826
KROGER 10OZ GRAPE CITRATE30142-806-38 041260008719 
LEADER 10OZ LEMON MAG CIT70000-0424-1096295135541
LEADER 10OZ CHERRY CIT70000-0575-1 096295141061 
LEADER 10OZ GRAPE MAG CIT70000-0576-1 096295141054 
MAJOR 10OZ LEMON MAG CITRATE0904-6787-44309046787440
MEIJER 10OZ LEMON MAG CIT41250-708-38713733459457
MEIJER 10OZ CHERRY CITRATE41250-769-38 713733459440 
PREMIER VALUE 10OZ LOW SOD LEM CIT68016-696-38840986035302
PREMIER VALUE 10OZ CHERRY CIT68016-701-38 840986035296 
PUBLIX 10OZ LEMON MAG CIT56062-266-38041415506732
PUBLIX 10OZ CHERRY CITRATE56062-264-38 041415505735 
QUALITY CHOICE 10OZ LEMON MAG CIT63868-929-38635515901254
QUALITY CHOICE 10OZ CHERRY CITRATE63868-018-38 635515901117 
REXALL 10OZ LEMON MAG CITRATE55910-183-38072785134188
REXALL 10OZ CHERRY CIT55910-961-38 072785134164 
REXALL 10OZ GRAPE MAG CIT55910-615-38 072785134171 
RITE AID 10OZ LEMON CITRATE11822-4330-2011822433006
RITE AID 10OZ CHERRY CITRATE11822-4303-2 011822433037 
SIGNATURE CARE 10OZ LEMON MAG CIT21130-709-38321130779155
SIGNATURE CARE 10OZ CHERRY CIT21130-165-38 321130789710 
SOUND BODY 10OZ LEMON MAG CIT50594-166-38072785114791
SUNMARK 10OZ LEMON MAG CIT70677-0051-1010939908445
SUNMARK 10OZ CHERRY CIT70677-0053-1 010939910448 
SWAN 10OZ LEMON MAG CITRATE0869-0166-38072785134058
SWAN 10OZ CHRY CITRATE0869-0164-38 308690693381 
TOPCARE 10OZ LEMON MAG CITRATE36800-709-38036800455290
TOPCARE 10OZ CHERRY CIT36800-164-38 036800455306 
UP&UP 10OZ LEMON MAG CIT11673-708-38072785128835
UP&UP 10OZ LEMON MAG CIT11673-666-38072785128835
WALGREENS 10OZ LEMON MAG CIT0363-8166-38311917201603
WALGREENS 10OZ CHERRY CIT0363-8164-38 311917201580 
WALGREENS 10OZ GRAPE MAG CIT0363-7162-38 311917201597 

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 

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 1st Expansion Press Release.

Link to Initial Press 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

  • “Best Choice Magnesium Citrate Saline Laxative, Cherry Flavor”
  • “Best Choice Magnesium Citrate Saline Laxative, Grape Flavor”
  • “CAREone Magnesium Citrate Saline Laxative, Cherry Flavor”
  • “CVS Magnesium Citrate Saline Laxative, Cherry Flavor”
  • “CVS Magnesium Citrate Saline Laxative, Grape Flavor”
  • “EQUALINE Magnesium Citrate Saline Laxative oral solution, Cherry Flavor”
  • “equate Magnesium Citrate Saline Laxative, Cherry Flavor”
  • “equate Magnesium Citrate Saline Laxative, Grape Flavor”
  • “Family Wellness Magnesium Citrate Saline Laxative, Cherry Flavor”
  • “GoodSense Magnesium Citrate Saline Laxative Oral Solution, Cherry Flavor”
  • “H-E-B Magnesium Citrate Oral Solution Saline Laxative, Cherry Flavor”
  • “H-E-B Magnesium Citrate Oral Solution Saline Laxative, Grape Flavor”
  • “HealthMart Magnesium Citrate Saline Laxative and Oral Solution, Cherry Flavor”
  • “Kroger Magnesium Citrate Saline Laxative, Grape Flavor”
  • “Leader Sugar-Free Magnesium Citrate Saline Laxative, Cherry Flavor”
  • “Leader Sugar-Free Magnesium Citrate Saline Laxative, Grape Flavor”
  • “Meijer Magnesium Citrate Sugar-Free, Low Sodium Saline Laxative, Cherry Flavor”
  • “Premier Value Magnesium Citrate Saline Laxative, Cherry Flavor”
  • “Publix Magnesium Citrate Saline Laxative, Cherry Flavor”
  • “QC Qualty Choice Magnesium Citrate Saline Laxative, Cherry Flavor”
  • “Rexall Magnesium Citrate Saline Laxative, Cherry Flavor”
  • “Rexall Magnesium Citrate Saline Laxative, Grape Flavor”
  • “Rite Aid Magnesium Citrate Saline Laxative, Cherry Flavor”
  • “Rite Aid Magnesium Citrate Saline Laxative Sugar-free, Cherry Flavor”
  • “Signature Care Magnesium Citrate Saline Laxative, Cherry Flavor”
  • “Sunmark Magnesium Citrate Saline Laxative, Cherry Flavor”
  • “Swan Magnesium Citrate Saline Laxative, Cherry Flavor”
  • “TopCare Magnesium Citrate Saline Laxative, Cherry Flavor”
  • “Walgreens Dye-Free Magnesium Citrate Saline Laxative, Cherry Flavor (red label)”
  • “Walgreens Dye-Free Magnesium Citrate Saline Laxative, Cherry Flavor (blue label)”
  • “Walgreens Dye-Free Magnesium Citrate Saline Laxative, Grape Flavor (purple label)”
  • “Walgreens Dye-Free Magnesium Citrate Saline Laxative, Grape Flavor (blue label)”
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