FDA recall D-0970-2022

Vi-Jon, LLC · Class II · drug

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

Reason for recall

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.

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2022-05-05
Report date
2022-06-08
Termination date
2024-07-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Smyrna, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0970-2022