Magnesium Citrate Oral Solution, packaged in a 10 fl. oz. (296 mL) glass bottle, OTC, labeled as:...

FDA Drug Recall #D-1054-2017 — Class II — July 17, 2017

Recall Summary

Recall Number D-1054-2017
Classification Class II — Moderate risk
Date Initiated July 17, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Vi-Jon, Inc.
Location Smyrna, TN
Product Type Drugs
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

Lot / 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

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D-0520-2019 Class II Topical Solution USP Hydrogen Peroxide First Ai... Feb 20, 2019
D-0006-2018 Class III Magnesium Citrate Oral Solution Cherry Flavor, ... Sep 13, 2017
D-0073-2018 Class III Equate Beauty Clarifying Face Daily Moisturizer... Sep 13, 2017

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.