FDA Recall D-1503-2022
Vi-Jon, LLC · Smyrna, TN
Class I — life-threatening Terminated 664 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Kroger, Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), Distributed By The Kroger CO Cincinnati, Ohio 45202; NDC 30142-899-38 UPC 0 41260 00182 6
Reason for recall
Microbial contamination of non-sterile products.
Recall record
- Recall number
D-1503-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Distributed Nationwide in the USA as well as Canada and Panama.
- Recall initiated
- 2022-07-15
- Classified by FDA Center
- 2022-09-09
- FDA published
- 2022-09-21
- Terminated
- 2024-05-09
- Recalling firm
- Vi-Jon, LLC
- Firm location
- Smyrna, TN
Drug identification
- Brand name(s)
- MAGNESIUM CITRATE
- Generic name(s)
- MAGNESIUM CITRATE
- Manufacturer(s)
- The Kroger Co.
- NDC(s)
30142-899- Route(s)
- ORAL