Drug Enforcement D-573-2013

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

Classification

Class III

Report Date

June 12, 2013

Termination Date

November 26, 2014

Product Information

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.
Product quantity
818,064 (12-gm) tubes and 836,376 (30-gm) tubes
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.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide and Puerto Rico, and Panama. Military distribution made.

Location & Firm

Recalling firm
Novartis Consumer Health
Address
10401 Hwy 6, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-573-2013
Event ID
64372
Recall initiation date
February 19, 2013
Center classification date
June 6, 2013
Code info
(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
More code info
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