July 2017 FDA Recall Drug by Vi-jon, Inc.
D-1054-2017 - Microbial contamination of non-sterile products

This Class II drug recall was voluntarily initiated by Vi-jon, Inc. on July 17, 2017 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed in GA, PA, NJ and the recall is currently terminated.

Recall Number: D-1054-2017

Reason for Recall
Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis.
Initiated
07-17-2017
Reported
08-09-2017
Quantity
101,244 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77771
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Vi-Jon, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
GA, PA, NJ
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-24-2020
Product Description About Product Description
Full technical description of the product.
Magnesium Citrate Oral Solution, packaged in a 10 fl. oz. (296 mL) glass bottle, OTC, labeled as: a) GoodSense Magnesium Citrate Oral Solution Saline Laxative Very Low Sodium, UPC# 846036007381, NDC 50804-686-38, Distributed by: Geiss, Desitin &Dunn, Inc., Peachtree City, GA 30269; b) Premier Value Magnesium Citrate Oral Solution saline laxative very low sodium, UPC# 840986010255, NDC 68016-826-38, Distributed by: Chain Drug Consortium, Boca Raton, FL 33431; c) Swan Very Low Sodium Citroma Magnesium Citrate, UPC# 308690686383, NDC 0869-686-38, Distributed by: Vi-Jon, Smyrna, TN, 37167 ; d) ShopRite Magnesium Citrate Oral Solution Saline Laxative Low Sodium, UPC# 041190211487, NDC 41190-686-38, Distributed by: Wakefern Food Corporation, Jamesburg, NJ 08831

Batch or Lot Expiration Information

Lot# : a) 0341906, Exp 12/2018; b) 0341906 Exp 12/2018; c) 0341906, Exp 12/2018; 0343709, Exp 1/2019 d) 0343709 Exp 1/2019