FDA Drug Recalls

Recalls / Class II

Class IID-0970-2022

Product

Equate Tartar Control Plus (Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%) Antiseptic Mouthrise Plus, Antigingivitis/Antiplaque, Blue Mint, 1.5 Liter (50.7 FL OZ) bottle, Distributed By: Wal-Mart Stores, Inc., Bentonville, AR 72716, UPC 6 81131 14800 9

Affected lot / code info
Lots: 0559696, 0563041, Exp. 02/2024

Why it was recalled

Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of specification for the four active ingredients.

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
75,064 bottles
Distribution pattern
Nationwide in the USA

Timeline

Recall initiated
2022-05-05
FDA classified
2022-05-27
Posted by FDA
2022-06-08
Terminated
2024-07-05
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0970-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.