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VI-Jon, LLC Expands Voluntary Worldwide Recall of All Flavors and Lots within Expiry of Magnesium Citrate Saline Laxative Oral Solution Due to Microbial Contamination

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


Company Announcement

Vi-Jon, LLC is revising a previously reported list of all flavors of Magnesium Citrate Saline Laxative Oral Solution within expiry that were voluntarily recalled to the consumer level to include product that was distributed in the United States, Canada and Panama. This 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 includes the Cherry flavor and Grape flavor noted below in the table.

Affected BrandNDC #UPC #
BEST CHOICE 10OZ LEMON MAG CITRATE63941-533-38070038200499
BEST CHOICE 10OZ CHERRY CITRAT63941-516-38070038587903
BEST CHOICE 10OZ GRAPE CITRATE63941-162-38070038662204
CARE ONE 10OZ LEMON MAG CI72476-001-38341520313226
CARE ONE 10OZ CHERRY CIT72476-002-38341520000553
CARIBA 10OZ LEMON MAG CITRAT67860-166-38646702057012
CVS 10OZ LEMON MAG CIT63868-929-38050428335178
CVS 10OZ LEMON MAG CIT69842-983-38050428305942
CVS 10OZ CHERRY CITRAT69842-647-38050428297339
CVS 10OZ CHERRY CITRAT69842-647-3800050428285152
CVS 10OZ CLR GRAPE CITRATE69842-763-38050428307458
CVS 10OZ CLR GRAPE CITRATE69842-763-3800050428325032
DISCOUNT DRUG MART 10OZ LEMON MAG CITRAT53943-166-38093351028205
EQUALINE 10OZ LEMON MAG CI41163-709-38041163500679
EQUALINE 10OZ CHERRY CITRATE41163-769-38041163500686
EQUATE 10OZ LEMON MAG CIT SR49035-506-38681131287142
EQUATE 10OZ CHERRY CIT SRP49035-593-38681131287166
EQUATE 10OZ GRAPE MAG CIT SR49035-592-38681131287159
EXCHANGE SELECT 10OZ LEMON MAG CIT55301-166-38614299404205
FAMILY WELLNESS 10OZ LEMON CITRATE55319-666-38032251580826
FAM WELLNS 10OZ CHERRY CITRATE55319-164-38032251577888
GOOD SENSE 10OZ LEMON MAG CI50804-166-38846036007374
GOOD SENSE 10OZ CHERRY CITRATE50804-164-38846036007398
HARRIS TEETER 10OZ LEMON MAG CITRATE72036-002-38072036726124
HEB 10OZ LEMON MAG CITRATE37808-769-38041220510863
HEB 10OZ CHERRY CITRAT37808-673-3800041220510870
HEB 10OZ GRAPE MAG CITRATE37808-695-3800041220510887
HEALTH MART 10OZ LEMON MAG CIT62011-0380-1052569142158
HEALTH MART 10OZ CHERRY CI62011-0381-1052569142165
KROGER 10OZ LEMON MAG CITRAT30142-899-38041260001826
KROGER 10OZ GRAPE CITRAT30142-806-38041260008719
LEADER 10OZ LEMON MAG CI70000-0424-1096295135541
LEADER 10OZ CHERRY CIT70000-0575-1096295141061
LEADER 10OZ GRAPE MAG CI70000-0576-1096295141054
MAJOR 10OZ LEMON MAG CITRATE0904-6787-44309046787440
MEIJER 10OZ LEMON MAG CI41250-708-38713733459457
MEIJER 10OZ CHERRY CITRATE41250-769-38713733459440
PREMIER VALUE 10OZ LOW SOD LEM CIT68016-696-38840986035302
PREMIER VALUE 10OZ CHERRY CI68016-701-38840986035296
PUBLIX 10OZ LEMON MAG CI56062-266-38041415506732
PUBLIX 10OZ CHERRY CITRATE56062-264-38041415505735
QUALITY CHOICE 10OZ LEMON MAG CI63868-929-38635515901254
QUALITY CHOICE 10OZ CHERRY CITRATE63868-018-38635515901117
REXALL 10OZ LEMON MAG CITRAT55910-183-38072785134188
REXALL 10OZ CHERRY CIT55910-961-38072785134164
REXALL 10OZ GRAPE MAG CI55910-615-38072785134171
RITE AID 10OZ LEMON CITRAT11822-4330-2011822433006
RITE AID 10OZ CHERRY CITRATE11822-4303-2011822433037
SIGNATURE CARE 10OZ LEMON MAG CI21130-709-38321130779155
SIGNATURE CARE 10OZ CHERRY CIT21130-165-38321130789710
SOUND BODY 10OZ LEMON MAG CI50594-166-38072785114791
SUNMARK 10OZ LEMON MAG CIT70677-0051-1010939908445
SUNMARK 10OZ CHERRY CI70677-0053-1010939910448
SWAN 10OZ LEMON MAG CITRAT0869-0166-38072785134058
SWAN 10OZ CHRY CITRATE0869-0164-38308690693381
TOPCARE 10OZ LEMON MAG CITRATE36800-709-38036800455290
TOPCARE 10OZ CHERRY CI36800-164-38036800455306
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 CI0363-8164-38311917201580
WALGREENS 10OZ GRAPE MAG CIT0363-7162-38311917201597

August 3, 2022 – The Recall product list has been updated to include the products noted below in Bold print.

CANADANPN #UPC #
Equate Canada 300 mL Lemon Magnesium CitrateNPN 80015316079068004923
Life 300 mL Lemon Magnesium CitratNPN 80015316057800856412
Life 300 mL Cherry Magnesium CitrateNPN 80015316057800856405
Personnelle 300 mL Lemon CitrateNPN 80015316055989029306
PanamaNDC #UPC #
CRUZ BLANC 10OZ LEMON MAG CITN/A308697403082

The product was distributed in the United States, Canada and Panama 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 ([email protected]) or phone call (615) 208-2441, 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 2nd Expansion Press Release
Link to 1st Expansion Press Release
Link to Initial Press Release


Company Contact Information

Media:
Joseph Meehan


Product Photos

Go to Source
Author: FDA

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