Key Takeaway

Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in 10 fl. oz. (296 mL) bottles, Labeled as a) CVS Health, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 028 by Vi-Jon, Inc. was recalled on September 13, 2017. The hazard: Failed Impurities/Degradation Specifications.

FDA Drug Class III Terminated

Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in 10 fl. oz. (296 mL) bottles, Labeled as a) CVS Health, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 028

Recalled: September 13, 2017 ~348,384 bottles units affected D-0005-2018

Description

Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in 10 fl. oz. (296 mL) bottles, Labeled as a) CVS Health, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; NDC 59779-667-38, UPC 05042842790; b) Swan Citroma, Distributed by: Vi-Jon One Swan Drive Smyrna, TN 37167, NDC 0869066738, UPC 308690667382; c) GoodSense, Distributed By: Geiss, Destin & Dunn, Inc. Peachtree City, GA 30269, NDC 50804-667-38, UPC 846036007374; d) Leader, Distributed By: Cardinal Health, Dublin, Ohio, 43017, NDC 3720511038, UPC 096295382433; e) Signature Care, Distributed By: Better Living Brands, LLC. P.O. Box 99, Pleasanton, CA 94566-0009, NDC 21130-667-38, UPC 321130779155; f) Discount Drug Mart Food Fair, Distributed By: Drug Mart-Food Fair Medina, Ohio 44256, NDC 5394301077, UPC 093351100383; g) Sunmark, Distributed By McKesson One Post Street San Francisco, CA 94104, NDC 4934869649, UPC 010939112330, h) Major, Distributed By: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 USA, NDC 0904630477, UPC 309046304777

Hazard / Reason

Failed Impurities/Degradation Specifications.

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in 10 fl. oz. (296 mL) bottles, Labeled as a) CVS Health, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 028

Drugs

Company Information

Vi-Jon, Inc.

Smyrna, TN, United States

View all 9 recalls by Vi-Jon, Inc. →

Distribution

United States and Canada

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