FDA Drug Recalls

Recalls / Class I

Class ID-1504-2022

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

meijer, magnesium citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544; NDC 41250-708-38 UPC 7 13733 45945 7

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
Notification channel
Press Release
Type
Voluntary: Firm initiated
Address
1 Swan Dr, Smyrna, Tennessee 37167-2099

Distribution

Quantity
L 22,965,330 C 10,070,526 G 8,064,834
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-1504-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.