May 2012 FDA Recall Drug by Grandpa Brands Co
D-1425-2012 - Superpotent; benzocaine

This Class II drug recall was voluntarily initiated by Grandpa Brands Co on May 9, 2012 for the product Drug. The FDA reported the reason for recall as superpotent; benzocaine. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1425-2012

Reason for Recall
Superpotent; benzocaine
Initiated
05-09-2012
Reported
08-01-2012
Quantity
Lot #C2501: 18150 pieces of gum (1 per package); Lot #B2111: 18129 pieces of gum (1 per package)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
61838
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Grandpa Brands Co
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-01-2013
Product Description About Product Description
Full technical description of the product.
Dent's Extra Strength Toothache Gum, (benzocaine 20%), Net Wt. .035 Oz.. (1 g) box, C.S. Dent & Co., Erlanger, KY

Batch or Lot Expiration Information

Lot# s C2501 & B2111