Why it was recalled
Failed Impurities/Degradation Specifications.
Product 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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
United States and Canada
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-0005-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 13, 2017
- FDA report date
- Oct 11, 2017
- Quantity
- 348,384 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vi-Jon, Inc.
Original FDA data
Every field from FDA enforcement report D-0005-2018, exactly as published.
Show all FDA fields
- City
- Smyrna
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 78099
- Address
- 1 Swan Dr
- 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.
- Postal code
- 37167-2099
- Report date
- Oct 11, 2017
- Product type
- Drugs
- Recall number
- D-0005-2018
- Classification
- Class III
- Recalling firm
- Vi-Jon, Inc.
- Product quantity
- 348,384 bottles
- Termination date
- Jan 16, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- United States and Canada
- Recall initiation date
- Sep 13, 2017
- Initial firm notification
- Letter
- Center classification date
- Oct 5, 2017