Recalls / Class I
Class ID-1503-2022
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Brand name
- Magnesium Citrate
- Generic name
- Magnesium Citrate
- Active ingredient
- Magnesium Citrate
- Route
- Oral
- NDC
- 30142-899
- FDA application
- M007
- Affected lot / code info
- Lot# 0557622, EXP 1/12/2024
Why it was recalled
Microbial contamination of non-sterile products.
Recalling firm
- Firm
- Vi-Jon, LLC
- Manufacturer
- The Kroger Co.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1 Swan Dr, Smyrna, Tennessee 37167-2099
Distribution
- Quantity
- 44,976 bottles
- Distribution pattern
- Distributed Nationwide in the USA as well as Canada and Panama.
Timeline
- Recall initiated
- 2022-07-15
- FDA classified
- 2022-09-09
- Posted by FDA
- 2022-09-21
- Terminated
- 2024-05-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1503-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.