Recalls / Class II

Class IID-1054-2017

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

Affected lot / code info

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

Why it was recalled

Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis.

Recalling firm

Firm

Vi-Jon, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1 Swan Dr, N/A, Smyrna, Tennessee 37167-2099

Distribution

Quantity

101,244 bottles

Distribution pattern

GA, PA, NJ

Timeline

Recall initiated

2017-07-17

FDA classified

2017-08-03

Posted by FDA

2017-08-09

Terminated

2020-01-24

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1054-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.