D-1054-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 9, 2017
- Initiation Date
- July 17, 2017
- Termination Date
- January 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 101,244 bottles
Product Description
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 Pattern
GA, PA, NJ
Code 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