FDA recall D-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

Reason for recall

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

Distribution

GA, PA, NJ

Key facts

Status

Terminated

Initiation date

2017-07-17

Report date

2017-08-09

Termination date

2020-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Smyrna, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1054-2017