Why it was recalled
Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis.
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
GA, PA, NJ
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1054-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 17, 2017
- FDA report date
- Aug 9, 2017
- Quantity
- 101,244 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vi-Jon, Inc.
Original FDA data
Every field from FDA enforcement report D-1054-2017, exactly as published.
Show all FDA fields
- City
- Smyrna
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 77771
- Address
- 1 Swan Dr
- 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
- Postal code
- 37167-2099
- Report date
- Aug 9, 2017
- Product type
- Drugs
- Recall number
- D-1054-2017
- Classification
- Class II
- Recalling firm
- Vi-Jon, Inc.
- Product quantity
- 101,244 bottles
- Termination date
- Jan 24, 2020
- Reason for recall
- Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- GA, PA, NJ
- Recall initiation date
- Jul 17, 2017
- Initial firm notification
- Letter
- Center classification date
- Aug 3, 2017