Drug product
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
D-0005-2018
Product summary
- Firm
- Vi-Jon, Inc.
- Event
- Event 78099
- Status
- Terminated
- Classification
- Class III
- Quantity
- 348,384 bottles
- Official record key
drug-enforcement:D-0005-2018
Official wording
Reason: Failed Impurities/Degradation Specifications.
Code information: Lot #: a) 0326166 Exp. 07/2018; b) 0326164, Exp. 07/2018; 0326730, Exp. 08/2018; c) 0326183, Exp. 07/2018; 0326730 Exp. 08/2018; d) 0326183, Exp. 07/2018, e) 0326183, Exp. 07/2018, f) 0326730 Exp. 08/2018,g) 0326736, Exp. 08/2018, 0341351 Exp. 11/2018, h) 0326736, Exp. 08/2018.
Distribution pattern: United States and Canada
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications