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Recall Observatory FDA recall evidence

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

D-0970-2022

May 05, 2022

Class II

Product summary

Firm
Vi-Jon, LLC
Event
Event 90128
Status
Terminated
Classification
Class II
Quantity
75,064 bottles
Official record key
drug-enforcement:D-0970-2022

Official wording

Reason: 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.

Code information: Lots: 0559696, 0563041, Exp. 02/2024

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent