COMPANY ANNOUNCEMENT
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
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.
Read Announcement View Product PhotosSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason DescriptionPotential Gluconacetobacter liquefaciens contamination
- Company Name:
- Vi-Jon, LLC
- Brand Name:
-
Brand Name(s)Multiple Brands
- Product Description:
-
Product DescriptionMagnesium 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 CITRATE | 63941-533-38 | 070038200499 |
| BEST CHOICE 10OZ CHERRY CITRATE | 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 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 |
| CVS 10OZ CHERRY CITRATE | 69842-647-38 | 050428297339 |
| CVS 10OZ CHERRY CITRATE | 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 CITRATE | 53943-166-38 | 093351028205 |
| EQUALINE 10OZ LEMON MAG CIT | 41163-709-38 | 041163500679 |
| EQUALINE 10OZ CHERRY CITRATE | 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 LEMON MAG CITRATE | 72036-002-38 | 072036726124 |
| HEB 10OZ LEMON MAG CITRATE | 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 MAG CITRATE | 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 |
| PREMIER 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 10OZ CHERRY CITRATE | 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 CARE 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 MAG CITRATE | 0869-0166-38 | 072785134058 |
| SWAN 10OZ CHRY CITRATE | 0869-0164-38 | 308690693381 |
| TOPCARE 10OZ LEMON MAG CITRATE | 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 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 3rd Expansion Press Release
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
