FDA recall D-576-2013

Novartis Consumer Health · Class III · drug

Product

Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) Tubes and 30 gm (1 oz) Tubes packaged in one box, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300676249438. (Club Pack), NDC 0067-6295-43

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2013-02-19
Report date
2013-06-12
Termination date
2014-11-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lincoln, NE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-576-2013