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Recall Observatory FDA recall evidence

Drug product

Grapefruit anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Tocopheryl Acetate,*** Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5

D-359-2014

June 21, 2013

Class III

Product summary

Firm
Tween Brands Inc
Event
Event 66233
Status
Terminated
Classification
Class III
Quantity
18,492 bottles
Official record key
drug-enforcement:D-359-2014

Official wording

Reason: Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.

Code information: Style #190848 & 190872

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Error