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Class II: temporary or reversible health riskTerminated

Grandpa Brands Dent's Extra Strength Toothache Gum Recall

Dent's Extra Strength Toothache Gum, (benzocaine 20%)

Grandpa Brands Co · Erlanger, KY

Risk level
Class II
Reported by FDA
Aug 1, 2012
Recall ID
D-1425-2012
Check your lot numberHow we source this data

Summary

Grandpa Brands recalled Dent's Extra Strength Toothache Gum starting May 9, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1425-2012 on Aug 1, 2012. Reason: Superpotent; benzocaine. Status: Terminated.

Why it was recalled

Superpotent; benzocaine

Product description

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

Lot numbers, UPCs & expiration codes

Lot #s C2501 & B2111

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1425-2012
Classification
Class II
Status
Terminated
Recall initiated
May 9, 2012
FDA report date
Aug 1, 2012
Quantity
Lot #C2501: 18150 pieces of gum (1 per package); Lot #B2111: 18129 pieces of gum (1 per package)
Recall type
Voluntary: Firm initiated
Recalling firm
Grandpa Brands Co

Original FDA data

Every field from FDA enforcement report D-1425-2012, exactly as published.

Show all FDA fields
City
Erlanger
State
KY
Status
Terminated
Country
United States
Event ID
61838
Address
1820 Airport Exchange Blvd
Code information
Lot #s C2501 & B2111
Postal code
41018-3192
Report date
Aug 1, 2012
Product type
Drugs
Recall number
D-1425-2012
Classification
Class II
Recalling firm
Grandpa Brands Co
Product quantity
Lot #C2501: 18150 pieces of gum (1 per package); Lot #B2111: 18129 pieces of gum (1 per package)
Termination date
Mar 1, 2013
Reason for recall
Superpotent; benzocaine
Voluntary / mandated
Voluntary: Firm initiated
Product description
Dent's Extra Strength Toothache Gum, (benzocaine 20%), Net Wt. .035 Oz.. (1 g) box, C.S. Dent & Co., Erlanger, KY
Distribution pattern
Nationwide
Recall initiation date
May 9, 2012
Initial firm notification
Letter
Center classification date
Jul 24, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1425-2012, published Aug 1, 2012. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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