Summary

Company Announcement Date:
August 04, 2022
FDA Publish Date:
August 04, 2022
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 Brand NDC # UPC #
BEST CHOICE 10OZ LEMON MAG CITRATE 63941-533-38 070038200499
BEST CHOICE 10OZ CHERRY CITRAT 63941-516-38 070038587903
BEST CHOICE 10OZ GRAPE CITRATE 63941-162-38 070038662204
CARE ONE 10OZ LEMON MAG CI 72476-001-38 341520313226
CARE ONE 10OZ CHERRY CIT 72476-002-38 341520000553
CARIBA 10OZ LEMON MAG CITRAT 67860-166-38 646702057012
CVS 10OZ LEMON MAG CIT 63868-929-38 050428335178
CVS 10OZ LEMON MAG CIT 69842-983-38 050428305942
CVS 10OZ CHERRY CITRAT 69842-647-38 050428297339
CVS 10OZ CHERRY CITRAT 69842-647-38 00050428285152
CVS 10OZ CLR GRAPE CITRATE 69842-763-38 050428307458
CVS 10OZ CLR GRAPE CITRATE 69842-763-38 00050428325032
DISCOUNT DRUG MART 10OZ LEMON MAG CITRAT 53943-166-38 093351028205
EQUALINE 10OZ LEMON MAG CI 41163-709-38 041163500679
EQUALINE 10OZ CHERRY CITRATE 41163-769-38 041163500686
EQUATE 10OZ LEMON MAG CIT SR 49035-506-38 681131287142
EQUATE 10OZ CHERRY CIT SRP 49035-593-38 681131287166
EQUATE 10OZ GRAPE MAG CIT SR 49035-592-38 681131287159
EXCHANGE SELECT 10OZ LEMON MAG CIT 55301-166-38 614299404205
FAMILY WELLNESS 10OZ LEMON CITRATE 55319-666-38 032251580826
FAM WELLNS 10OZ CHERRY CITRATE 55319-164-38 032251577888
GOOD SENSE 10OZ LEMON MAG CI 50804-166-38 846036007374
GOOD SENSE 10OZ CHERRY CITRATE 50804-164-38 846036007398
HARRIS TEETER 10OZ LEMON MAG CITRATE 72036-002-38 072036726124
HEB 10OZ LEMON MAG CITRATE 37808-769-38 041220510863
HEB 10OZ CHERRY CITRAT 37808-673-38 00041220510870
HEB 10OZ GRAPE MAG CITRATE 37808-695-38 00041220510887
HEALTH MART 10OZ LEMON MAG CIT 62011-0380-1 052569142158
HEALTH MART 10OZ CHERRY CI 62011-0381-1 052569142165
KROGER 10OZ LEMON MAG CITRAT 30142-899-38 041260001826
KROGER 10OZ GRAPE CITRAT 30142-806-38 041260008719
LEADER 10OZ LEMON MAG CI 70000-0424-1 096295135541
LEADER 10OZ CHERRY CIT 70000-0575-1 096295141061
LEADER 10OZ GRAPE MAG CI 70000-0576-1 096295141054
MAJOR 10OZ LEMON MAG CITRATE 0904-6787-44 309046787440
MEIJER 10OZ LEMON MAG CI 41250-708-38 713733459457
MEIJER 10OZ CHERRY CITRATE 41250-769-38 713733459440
PREMIER VALUE 10OZ LOW SOD LEM CIT 68016-696-38 840986035302
PREMIER VALUE 10OZ CHERRY CI 68016-701-38 840986035296
PUBLIX 10OZ LEMON MAG CI 56062-266-38 041415506732
PUBLIX 10OZ CHERRY CITRATE 56062-264-38 041415505735
QUALITY CHOICE 10OZ LEMON MAG CI 63868-929-38 635515901254
QUALITY CHOICE 10OZ CHERRY CITRATE 63868-018-38 635515901117
REXALL 10OZ LEMON MAG CITRAT 55910-183-38 072785134188
REXALL 10OZ CHERRY CIT 55910-961-38 072785134164
REXALL 10OZ GRAPE MAG CI 55910-615-38 072785134171
RITE AID 10OZ LEMON CITRAT 11822-4330-2 011822433006
RITE AID 10OZ CHERRY CITRATE 11822-4303-2 011822433037
SIGNATURE CARE 10OZ LEMON MAG CI 21130-709-38 321130779155
SIGNATURE CARE 10OZ CHERRY CIT 21130-165-38 321130789710
SOUND BODY 10OZ LEMON MAG CI 50594-166-38 072785114791
SUNMARK 10OZ LEMON MAG CIT 70677-0051-1 010939908445
SUNMARK 10OZ CHERRY CI 70677-0053-1 010939910448
SWAN 10OZ LEMON MAG CITRAT 0869-0166-38 072785134058
SWAN 10OZ CHRY CITRATE 0869-0164-38 308690693381
TOPCARE 10OZ LEMON MAG CITRATE 36800-709-38 036800455290
TOPCARE 10OZ CHERRY CI 36800-164-38 036800455306
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
WALGREENS 10OZ CHERRY CI 0363-8164-38 311917201580
WALGREENS 10OZ GRAPE MAG CIT 0363-7162-38 311917201597

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

CANADA NPN # UPC #
Equate Canada 300 mL Lemon Magnesium Citrate NPN 80015316 079068004923
Life 300 mL Lemon Magnesium Citrat NPN 80015316 057800856412
Life 300 mL Cherry Magnesium Citrate NPN 80015316 057800856405
Personnelle 300 mL Lemon Citrate NPN 80015316 055989029306
Panama NDC # UPC #
CRUZ BLANC 10OZ LEMON MAG CIT N/A 308697403082

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
615-208-2441


Product Photos