FDA Drug Recalls

Recalls / Class I

Class ID-1175-2022

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

CVS Health Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 30594 2.

Affected lot / code info
Lot: 0556808 Exp. 12/2023

Why it was recalled

Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens

Recalling firm

Firm
Vi-Jon, LLC
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
1 Swan Dr, N/A, Smyrna, Tennessee 37167-2099

Distribution

Quantity
98,958 bottles
Distribution pattern
Distributed Nationwide in the USA

Timeline

Recall initiated
2022-06-13
FDA classified
2022-07-05
Posted by FDA
2022-07-13
Terminated
2024-05-06
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1175-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class I recall: drug · FDA Drug Recalls