Multi-event September 2017 FDA Recall Drug by Vi-jon, Inc.
This Multi-event Class III drug recall was voluntarily initiated by Vi-jon, Inc. on September 13, 2017 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications.. The product was distributed in United States and Canada and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0005-2018
Failed Impurities/Degradation Specifications.
09-13-2017
10-11-2017
348,384 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Vi-Jon, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
United States and Canada
01-16-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration 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.
Recall Number: D-0006-2018
Failed Impurities/Degradation Specifications.
09-13-2017
10-11-2017
87,972 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Vi-Jon, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
United States and Canada
01-16-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Magnesium Citrate Oral Solution Cherry Flavor, 1.745 g 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 6984238038, UPC 050428418321, b) Meijer, Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544, NDC 4125038038, UPC 708820824294, c) Life Brand, Manufactured for: Shoppers Drug Mark/Pharmaprix Toronto, UPC 057800856405
Batch or Lot Expiration Information
Lot# : 0323439 Exp. 07/2018
