Recalls / Class I
Class ID-1506-2022
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
Rexall, Magnesium Citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Distributed By Dolgencorp. LLC 100 Mission Ridge, Goodlettsville, TN 37072 or Distributed By Old East Main Co. 100 Mission Ridge Goodlettsville, TN 37072; NDC 55910-183-38, UPC 0 72785 13418 8
- Brand name
- Citroma
- Generic name
- Magnesium Citrate
- Active ingredient
- Magnesium Citrate
- Route
- Oral
- NDC
- 55910-183
- FDA application
- M007
- Affected lot / code info
- Lot # 0511629, EXP 12/4/2022; 0562243, EXP 2/17/2024
Why it was recalled
Microbial contamination of non-sterile products.
Recalling firm
- Firm
- Vi-Jon, LLC
- Manufacturer
- Old East Main Co.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1 Swan Dr, Smyrna, Tennessee 37167-2099
Distribution
- Quantity
- 42,912 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-1506-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.