Drug product
Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal), a) 12 g (.42 oz) Tube, NDC 0067-3999-12, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300673999121, (Vertical Pack) and b) packaged in a horizontal package12 gm (.42 oz) Tube, NDC 0067-3999-42, Novartis Consumer Health, Inc., Parsippany, NJ. UPC code: 300673999428.
D-575-2013
Product summary
- Event
- Event 64372
- Status
- Terminated
- Classification
- Class III
- Quantity
- 219,600 tubes
- Official record key
drug-enforcement:D-575-2013
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 number and exp date: 10104145 30-Apr-2013. (Vertical package) and Lot number and exp date: 10109587 30-Apr-2013, 10111508 31-May-2013; 10119095 31-Jul-2013 and 10119096 30-Sep-2013 (Horizontal package).
Distribution pattern: Nationwide and Puerto Rico, and Panama. Military distribution made.
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing