Vi-Jon, LLC is expanding its voluntary recall to include all lots of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) within expiry to the consumer level. The recall was initiated after 3rd Party and Vi-Jon, LLC 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 has received one report of an adverse reaction potentially related to this recall. Vi-Jon, LLC is in the process of investigating this report.
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.
The affected brands of Magnesium Citrate Laxative Oral Solution Lemon Flavor manufactured at Vi-Jon, LLC in Smyrna, TN are:
| Affected Brand | NDC # | UPC # |
|---|---|---|
| BEST CHOICE 10OZ LEMON MAG CIT | 63941-533-38 | 070038200499 |
| CARE ONE 10OZ LEMON MAG CIT | 72476-001-38 | 341520313226 |
| 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 |
| DISCOUNT DRUG MART 10OZ LEMON MAG CITRATE | 53943-166-38 | 093351028205 |
| EQUALINE 10OZ LEMON MAG CIT | 41163-709-38 | 041163500679 |
| EQUATE 10OZ LEMON MAG CIT SRP | 49035-506-38 | 681131287142 |
| EXCHANGE SELECT 10OZ LEMON MAG CIT | 55301-166-38 | 614299404205 |
| FAMILY WELLNESS 10OZ LEMON CITRATE | 55319-666-38 | 032251580826 |
| GOOD SENSE 10OZ LEMON MAG CIT | 50804-166-38 | 846036007374 |
| HARRIS TEETER 10OZ LEMON MAG CITRATE | 72036-002-38 | 072036726124 |
| HEB 10OZ LEMON MAG CITRATE | 37808-769-38 | 041220510863 |
| HEALTH MART 10OZ LEMON MAG CIT | 62011-0380-1 | 052569142158 |
| KROGER 10OZ LEMON MAG CITRATE | 30142-899-38 | 041260001826 |
| LEADER 10OZ LEMON MAG CIT | 70000-0424-1 | 096295135541 |
| MAJOR 10OZ LEMON MAG CITRATE | 0904-6787-44 | 309046787440 |
| MEIJER 10OZ LEMON MAG CIT | 41250-708-38 | 713733459457 |
| PREMIER VALUE 10OZ LOW SOD LEM CIT | 68016-696-38 | 840986035302 |
| PUBLIX 10OZ LEMON MAG CIT | 56062-266-38 | 041415506732 |
| QUALITY CHOICE 10OZ LEMON MAG CIT | 63868-929-38 | 635515901254 |
| REXALL 10OZ LEMON MAG CITRATE | 55910-183-38 | 072785134188 |
| RITE AID 10OZ LEMON CITRATE | 11822-4330-2 | 011822433006 |
| SIGNATURE CARE 10OZ LEMON MAG CIT | 21130-709-38 | 321130779155 |
| SOUND BODY 10OZ LEMON MAG CIT | 50594-166-38 | 072785114791 |
| SUNMARK 10OZ LEMON MAG CIT | 70677-0051-1 | 010939908445 |
| SWAN 10OZ LEMON MAG CITRATE | 0869-0166-38 | 072785134058 |
| TOPCARE 10OZ LEMON MAG CITRATE | 36800-709-38 | 036800455290 |
| 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 |
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.
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.
Original recall and updates at FDA