Safety Report: Vi-Jon, LLC Magnesium Citrate Saline Laxative Oral Solution - recalled due to Microbial contamination, USA

United States

Smyrna, TN, 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 product was distributed Nationwide to wholesale and retail outlets. To date, Vi-Jon, LLC has received one report of an adverse reaction potentially related to this recall.

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.

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: BEST CHOICE 10OZ LEMON MAG CIT. NDC # 63941-533-38. UPC # 70038200499.
- Affected Brand: CARE ONE 10OZ LEMON MAG CIT. NDC # 72476-001-38. UPC # 341520313226.
- Affected Brand: CARIBA 10OZ LEMON MAG CITRATE. NDC # 67860-166-38. UPC # 646702057012.
- Affected Brand: CRUZ BLANC 10OZ LEMON MAG CIT. NDC # N/A. UPC # 308697403082.
- Affected Brand: CVS 10OZ LEMON MAG CIT. NDC # 63868-929-38. UPC # 50428335178.
- Affected Brand: CVS 10OZ LEMON MAG CIT. NDC # 69842-983-38. UPC # 50428305942.
- Affected Brand: DISCOUNT DRUG MART 10OZ LEMON MAG CITRATE. NDC # 53943-166-38. UPC # 93351028205.
- Affected Brand: EQUALINE 10OZ LEMON MAG CIT. NDC # 41163-709-38. UPC # 41163500679.
- Affected Brand: EQUATE 10OZ LEMON MAG CIT SRP. NDC # 49035-506-38. UPC # 681131287142.
- Affected Brand: EXCHANGE SELECT 10OZ LEMON MAG CIT. NDC # 55301-166-38. UPC # 614299404205.
- Affected Brand: FAMILY WELLNESS 10OZ LEMON CITRATE. NDC # 55319-666-38. UPC # 32251580826.
- Affected Brand: GOOD SENSE 10OZ LEMON MAG CIT. NDC # 50804-166-38. UPC # 846036007374.
- Affected Brand: HARRIS TEETER 10OZ LEMON MAG CITRATE. NDC # 72036-002-38. UPC # 72036726124.
- Affected Brand: HEB 10OZ LEMON MAG CITRATE. NDC # 37808-769-38. UPC # 41220510863.
- Affected Brand: HEALTH MART 10OZ LEMON MAG CIT. NDC # 62011-0380-1. UPC # 52569142158.
- Affected Brand: KROGER 10OZ LEMON MAG CITRATE. NDC # 30142-899-38. UPC # 41260001826.
- Affected Brand: LEADER 10OZ LEMON MAG CIT. NDC # 70000-0424-1. UPC # 96295135541.
- Affected Brand: MAJOR 10OZ LEMON MAG CITRATE. NDC # 0904-6787-44. UPC # 309046787440.
- Affected Brand: MEIJER 10OZ LEMON MAG CIT. NDC # 41250-708-38. UPC # 713733459457.
- Affected Brand: PREMIER VALUE 10OZ LOW SOD LEM CIT. NDC # 68016-696-38. UPC # 840986035302.
- Affected Brand: PUBLIX 10OZ LEMON MAG CIT. NDC # 56062-266-38. UPC # 41415506732.
- Affected Brand: QUALITY CHOICE 10OZ LEMON MAG CIT. NDC # 63868-929-38. UPC # 635515901254.
- Affected Brand: REXALL 10OZ LEMON MAG CITRATE. NDC # 55910-183-38. UPC # 72785134188.
- Affected Brand: RITE AID 10OZ LEMON CITRATE. NDC # 11822-4330-2. UPC # 11822433006.
- Affected Brand: SIGNATURE CARE 10OZ LEMON MAG CIT. NDC # 21130-709-38. UPC # 321130779155.
- Affected Brand: SOUND BODY 10OZ LEMON MAG CIT. NDC # 50594-166-38. UPC # 72785114791.
- Affected Brand: SUNMARK 10OZ LEMON MAG CIT. NDC # 70677-0051-1. UPC # 10939908445.
- Affected Brand: SWAN 10OZ LEMON MAG CITRATE. NDC # 0869-0166-38. UPC # 72785134058.
- Affected Brand: TOPCARE 10OZ LEMON MAG CITRATE. NDC # 36800-709-38. UPC # 36800455290.
- Affected Brand: UP&UP 10OZ LEMON MAG CIT. NDC # 11673-708-38. UPC # 72785128835.
- Affected Brand: UP&UP 10OZ LEMON MAG CIT. NDC # 11673-666-38. UPC # 72785128835.
- Affected Brand: WALGREENS 10OZ LEMON MAG CIT. NDC # 0363-8166-38. UPC # 311917201603.

Vi-Jon, LLC is continuing their investigation into the cause of the problem. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company name: Vi-Jon, LLC
Brand name: Multiple brand names
Product recalled: Magnesium Citrate Saline Laxative Oral Solution, Lemon Flavor
Reason of the recall: Microbial contamination with Gluconacetobacter liquefaciens
FDA Recall date: July 15, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vi-jon-llc-expands-voluntary-nationwide-recall-magnesium-citrate-saline-laxative-oral-solution-lemon