FindMyRecallSubscribe
Class III: unlikely to cause harmTerminated

Novartis Lamisil AT Cream Recall

Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Con…

Novartis Consumer Health · Lincoln, NE

Risk level
Class III
Reported by FDA
Jun 12, 2013
Recall ID
D-573-2013
Check your lot numberHow we source this data

Summary

Novartis Consumer Health recalled Novartis Lamisil AT Cream starting Feb 19, 2013. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-573-2013 on Jun 12, 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

Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany, NJ. (a)12 gm (.42 oz), packaged with UPC code 300673998421 and NDC code: 0067-3998-42; (b) 12 gm (.42 oz), packaged with UPC code: 300673998124 and NDC code: 0067-3998-12; (c) 30 gm (1 oz), packaged with UPC code: 300673998308 and NDC code: 0067-3998-30; (d) 30 gm (1 oz), packaged with UPC code: 300673998339 and NDC code: 0067-3998-33.

Lot numbers, UPCs & expiration codes

(12 gm) Lot numbers and Exp dates: 10109586 30-Apr-2013, 10116816 31 May 2013, 10117695 31-Jul-2013, 10120283 31-Aug-2013, 10104980 28-Feb-2013, 10108711 31-Mar-2013, 10111313 30-Apr-2013, 10111509 30-Apr-2013, 10115506 30-Jun-2013, 10117696 30-Jun-2013, 10120763 31-Aug-2013, 10122695 30-Sep-2013, 10104983 28-Feb-2013, 10108714 31-Mar-2013, 10119643 31-Jul-2013 (30 gm) Lot numbers and Exp dates: 10104979 28-Feb-2013 10108712 31-Mar-2013 10109588 30-Apr-2013 10111507 30-Apr-2013 10115133 31-May-2013 10115619 30-Jun-2013 10117694 31-Aug-2013 10120762 30-Sep-2013 10109981 31-Mar-2013 10111316 31-Mar-2013 10114223 31-May-2013 10117697 30-Jun-2013 10104982 28-Feb-2013 10108355 31-Mar-2013, 10112072 30-Apr-2013, 10112073 30-Apr-2013 10113501 31-May-2013, 10122772 31-Aug-2013

Where it was sold

Nationwide and Puerto Rico, and Panama. Military distribution made.

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-573-2013
Classification
Class III
Status
Terminated
Recall initiated
Feb 19, 2013
FDA report date
Jun 12, 2013
Quantity
818,064 (12-gm) tubes and 836,376 (30-gm) tubes
Recall type
Voluntary: Firm initiated
Recalling firm
Novartis Consumer Health

Original FDA data

Every field from FDA enforcement report D-573-2013, exactly as published.

Show all FDA fields
City
Lincoln
State
NE
Status
Terminated
Country
United States
Event ID
64372
Address
10401 Hwy 6
Code information
(12 gm) Lot numbers and Exp dates: 10109586 30-Apr-2013, 10116816 31 May 2013, 10117695 31-Jul-2013, 10120283 31-Aug-2013, 10104980 28-Feb-2013, 10108711 31-Mar-2013, 10111313 30-Apr-2013, 10111509 30-Apr-2013, 10115506 30-Jun-2013, 10117696 30-Jun-2013, 10120763 31-Aug-2013, 10122695 30-Sep-2013, 10104983 28-Feb-2013, 10108714 31-Mar-2013, 10119643 31-Jul-2013 (30 gm) Lot numbers and Exp dates: 10104979 28-Feb-2013 10108712 31-Mar-2013 10109588 30-Apr-2013 10111507 30-Apr-2013 10115133 31-May-2013 10115619 30-Jun-2013 10117694 31-Aug-2013 10120762 30-Sep-2013 10109981 31-Mar-2013 10111316 31-Mar-2013 10114223 31-May-2013 10117697 30-Jun-2013 10104982 28-Feb-2013 10108355 31-Mar-2013, 10112072 30-Apr-2013, 10112073 30-Apr-2013 10113501 31-May-2013, 10122772 31-Aug-2013
Postal code
68517-9626
Report date
Jun 12, 2013
Product type
Drugs
Recall number
D-573-2013
Classification
Class III
Recalling firm
Novartis Consumer Health
Product quantity
818,064 (12-gm) tubes and 836,376 (30-gm) tubes
Termination date
Nov 26, 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
Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany, NJ. (a)12 gm (.42 oz), packaged with UPC code 300673998421 and NDC code: 0067-3998-42; (b) 12 gm (.42 oz), packaged with UPC code: 300673998124 and NDC code: 0067-3998-12; (c) 30 gm (1 oz), packaged with UPC code: 300673998308 and NDC code: 0067-3998-30; (d) 30 gm (1 oz), packaged with UPC code: 300673998339 and NDC code: 0067-3998-33.
Distribution pattern
Nationwide and Puerto Rico, and Panama. Military distribution made.
Recall initiation date
Feb 19, 2013
Initial firm notification
Letter
Center classification date
Jun 6, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-573-2013, published Jun 12, 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.

How we source and update recall data · Report incorrect information

Other recent drug recalls