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
D-576-2013
Product summary
- Event
- Event 64372
- Status
- Terminated
- Classification
- Class III
- Quantity
- 41,400 Boxes
- Official record key
drug-enforcement:D-576-2013
Official wording
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.
Code information: Lot #: 10109590, 10111050, Exp 2/28/13.
Distribution pattern: Nationwide and Puerto Rico, and Panama. Military distribution made.
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing