FDA Recall D-1508-2022
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
Topcare health, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Cherry Flavor, 10 FL OZ (296 mL), Distributed By Topco Associates LLC Elk Grove Village, IL 60007; NDC 36800-164-38 UPC 0 36800 45530 6
Reason for recall
Microbial contamination of non-sterile products.
Recall record
- Recall number
D-1508-2022- 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)
- CITROMA
- Generic name(s)
- MAGESIUM CITRATE
- Manufacturer(s)
- Topco Associates LLC
- NDC(s)
36800-164- Route(s)
- ORAL