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

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Summary

Company announcement date:
FDA Publication Date:
Type of product:
Drugs

Reason for announcement:

Description of the reason for the recall

Potential contamination by Gluconacetobacter liquefaciens

Company Name:
Vi-Jon, LLC
Mark:
Product Description:

Product Description

Oral saline laxative solution with magnesium citrate


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 through the expiration date to the consumer level. This expansion includes all 10 FL OZ (296ml) lots of Magnesium Citrate Cherry Flavored and Grape Flavored Saline Oral Laxative Solution prior to the expiration date. On July 14, 2022, Vi-Jon, LLC recalled all lots of Oral Saline Laxative Solution Magnesium Citrate, Lemon Flavor, 10 FL OZ (296 ml) prior to the expiration date. The recall was initiated after third party microbial testing by Vi-Jon, LLC identified the presence of Gluconacetobacter liquefaciens.

Risk Statement: Immunocompromised patients consuming this product may be at increased risk of invasive infections caused by Gluconacetobacter liquefaciens which could have serious and life-threatening adverse health consequences. At this time, Vi-Jon, LLC is aware of 3 (three) reports of serious adverse reactions potentially related to this recall. Vi-Jon, LLC is investigating these reports.
The product is used for the relief of occasional constipation (irregularity) and generally produces a bowel movement in ½ to 6 hours. The product is packaged in a 10 oz clear round plastic bottle.

In addition to lemon flavor, the recall now includes cherry flavor and grape flavor listed below in the table in bold.

Brand concerned

NDC#

UPC #

BEST CHOICE 10OZ LEMON CITRATE MAG 63941-533-38 070038200499
BEST CHOICE CHERRY CITRATE 10OZ 63941-516-38 070038587903
BEST CHOICE 10OZ GRAPE CITRATE 63941-162-38 070038662204
CARE ONE 10OZ LEMON MAG CIT 72476-001-38 341520313226
CARE ONE 10OZ CHERRY CIT 72476-002-38 341520000553
CARIBA 10OZ LEMON CITRATE MAG 67860-166-38 646702057012
CRUZ WHITE 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
CVS 10OZ CHERRY CITRATE 69842-647-38 050428297339
CVS 10OZ CHERRY CITRATE 69842-647-38 00050428285152
GRAPE CITRATE CVS 10OZ CLR 69842-763-38 050428307458
GRAPE CITRATE CVS 10OZ CLR 69842-763-38 00050428325032
DISCOUNT DRUG MART 10OZ LEMON MAG CITRATE 53943-166-38 093351028205
EQUALINE 10OZ LEMON MAG CIT 41163-709-38 041163500679
EQUALINE CHERRY CITRATE 10OZ 41163-769-38 041163500686
EQUATE 10OZ LEMON MAG CIT SRP 49035-506-38 681131287142
EQUATE 10OZ CHERRY CIT SRP 49035-593-38 681131287166
EQUATE 10OZ GRAPE MAG CIT SRP 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 CIT 50804-166-38 846036007374
GOOD SENSE 10OZ CHERRY CITRATE 50804-164-38 846036007398
HARRIS TEETER 10OZ CITRATE MAG LEMON 72036-002-38 072036726124
HEB 10OZ LEMON CITRATE MAG 37808-769-38 041220510863
HEB 10OZ CHERRY CITRATE 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 CIT 62011-0381-1 052569142165
KROGER 10OZ LEMON CITRATE MAG 30142-899-38 041260001826
KROGER 10OZ GRAPE CITRATE 30142-806-38 041260008719
LEADER 10OZ LEMON MAG CIT 70000-0424-1 096295135541
LEADER 10OZ CHERRY CIT 70000-0575-1 096295141061
LEADER 10OZ GRAPE MAG CIT 70000-0576-1 096295141054
MAJOR 10OZ LEMON MAG CITRATE 0904-6787-44 309046787440
MEIJER 10OZ LEMON MAG CIT 41250-708-38 713733459457
MEIJER 10OZ CHERRY CITRATE 41250-769-38 713733459440
FIRST VALUE 10OZ LOW SOD LEM CIT 68016-696-38 840986035302
PREMIER VALUE 10OZ CHERRY CIT 68016-701-38 840986035296
PUBLIX 10OZ LEMON MAG CIT 56062-266-38 041415506732
PUBLIX CHERRY CITRATE 10OZ 56062-264-38 041415505735
QUALITY CHOICE 10OZ LEMON MAG CIT 63868-929-38 635515901254
QUALITY CHOICE 10OZ CHERRY CITRATE 63868-018-38 635515901117
REXALL 10OZ LEMON MAG CITRATE 55910-183-38 072785134188
REXALL 10OZ CHERRY CIT 55910-961-38 072785134164
REXALL 10OZ GRAPE MAG CIT 55910-615-38 072785134171
RITE AID 10OZ LEMON CITRATE 11822-4330-2 011822433006
RITE AID 10OZ CHERRY CITRATE 11822-4303-2 011822433037
SIGNATURE CARE 10OZ LEMON MAG CIT 21130-709-38 321130779155
SIGNATURE TREATMENT 10OZ CHERRY CIT 21130-165-38 321130789710
SOUND BODY 10OZ LEMON MAG CIT 50594-166-38 072785114791
SUNMARK 10OZ LEMON MAG CIT 70677-0051-1 010939908445
SUNMARK 10OZ CHERRY CIT 70677-0053-1 010939910448
SWAN 10OZ LEMON CITRATE MAG 0869-0166-38 072785134058
SWAN 10OZ CHRY CITRATE 0869-0164-38 308690693381
TOPCARE 10OZ CITRATE MAG LEMON 36800-709-38 036800455290
TOPCARE 10OZ CHERRY CIT 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 CIT 0363-8164-38 311917201580
WALGREENS 10OZ GRAPE MAG CIT 0363-7162-38 311917201597

The product was distributed nationwide to wholesale and retail outlets. Vi-Jon, LLC is continuing to investigate the cause of the issue.

Vi-Jon, LLC is notifying customers by phone and email and arranging for the return or destruction of all recalled products. Consumers who possess this recalled product should stop using it and return any remaining product to the place of purchase.

Consumers with questions regarding this recall may contact Vi-Jon, LLC via email ([email protected]) Monday through Friday, 7:30 a.m. to 4:30 p.m. Central Time. Consumers should contact their doctor or health care provider if they have experienced any problems that may be related to taking or using this pharmaceutical 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 the form or call 1-800-332-1088 to request a reporting form, then complete and return it to the address on the pre-addressed form, or submit it by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the United States Food and Drug Administration.

Link to the 3rd expansion press release

Link to the press release of the 1st expansion

Link to original press release


Company details

Media:
Mr. Joseph Meehan, Director of Sales and Marketing


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