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Class III: unlikely to cause harmTerminated

Novartis Consumer Health Lamisil AT Recall

Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (

Novartis Consumer Health · Lincoln, NE

Risk level
Class III
Reported by FDA
May 29, 2013
Recall ID
D-420-2013
Check your lot numberHow we source this data

Summary

Novartis Consumer Health recalled Lamisil AT starting Apr 19, 2013. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-420-2013 on May 29, 2013. Reason: Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot. Status: Terminated.

Why it was recalled

Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.

Product description

Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, Novartis Consumer Health, Parsippany, NJ 07054, NDC 0067-6171-85

Lot numbers, UPCs & expiration codes

Lot #: 10118124, Exp: Sept 2013

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-420-2013
Classification
Class III
Status
Terminated
Recall initiated
Apr 19, 2013
FDA report date
May 29, 2013
Quantity
3,828 Tubes
Recall type
Voluntary: Firm initiated
Recalling firm
Novartis Consumer Health

Original FDA data

Every field from FDA enforcement report D-420-2013, exactly as published.

Show all FDA fields
City
Lincoln
State
NE
Status
Terminated
Country
United States
Event ID
65021
Address
10401 Hwy 6
Code information
Lot #: 10118124, Exp: Sept 2013
Postal code
68517-9626
Report date
May 29, 2013
Product type
Drugs
Recall number
D-420-2013
Classification
Class III
Recalling firm
Novartis Consumer Health
Product quantity
3,828 Tubes
Termination date
Nov 4, 2014
Reason for recall
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, Novartis Consumer Health, Parsippany, NJ 07054, NDC 0067-6171-85
Distribution pattern
Nationwide
Recall initiation date
Apr 19, 2013
Initial firm notification
Letter
Center classification date
May 17, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-420-2013, published May 29, 2013. 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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