Drug Enforcement D-420-2013

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

May 29, 2013

Termination Date

November 4, 2014

Product Information

Product description
Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, Novartis Consumer Health, Parsippany, NJ 07054, NDC 0067-6171-85
Product quantity
3,828 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

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-420-2013
Event ID
65021
Recall initiation date
April 19, 2013
Center classification date
May 17, 2013
Code info
Lot #: 10118124, Exp: Sept 2013
More code info