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: 300673

FDA recall notice · announced June 12, 2013 · Novartis Consumer Health

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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.

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.

Notes

Distribution: Nationwide and Puerto Rico, and Panama. Military distribution made.
Lot/code information: (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
Quantity: 818,064 (12-gm) tubes and 836,376 (30-gm) tubes
Status: Terminated
Products in this recall event:
- 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, (Verti (D-575-2013)
- 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. (Clu (D-576-2013)
- Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-684-83 (physician sample product) and b) 100 gm tubes, NDC 63481-684-47 (the 100 g (D-577-2013)
- Target Up & Up, athlete's foot cream, full prescription strength, terbinafine hydrochloride 1% antifungal, 30 g (1 oz), compare to active ingredient in Lamisil, NDC 0067-6382-30 & UPC code: 3006763823 (D-574-2013)
- 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 (D-573-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.