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Recall Observatory FDA recall evidence

Drug product

Dent's Extra Strength Toothache Gum, (benzocaine 20%), Net Wt. .035 Oz.. (1 g) box, C.S. Dent & Co., Erlanger, KY

D-1425-2012

May 09, 2012

Class II

Product summary

Firm
Grandpa Brands Co
Event
Event 61838
Status
Terminated
Classification
Class II
Quantity
Lot #C2501: 18150 pieces of gum (1 per package); Lot #B2111: 18129 pieces of gum (1 per package)
Official record key
drug-enforcement:D-1425-2012

Official wording

Reason: Superpotent; benzocaine

Code information: Lot #s C2501 & B2111

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent