Why it was recalled
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.
Product description
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.
Lot numbers, UPCs & expiration codes
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).
Where it was sold
Nationwide and Puerto Rico, and Panama. Military distribution made.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-575-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 19, 2013
- FDA report date
- Jun 12, 2013
- Quantity
- 219,600 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Consumer Health
Original FDA data
Every field from FDA enforcement report D-575-2013, exactly as published.
Show all FDA fields
- City
- Lincoln
- State
- NE
- Status
- Terminated
- Country
- United States
- Event ID
- 64372
- Address
- 10401 Hwy 6
- 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).
- Postal code
- 68517-9626
- Report date
- Jun 12, 2013
- Product type
- Drugs
- Recall number
- D-575-2013
- Classification
- Class III
- Recalling firm
- Novartis Consumer Health
- Product quantity
- 219,600 tubes
- Termination date
- Nov 26, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide and Puerto Rico, and Panama. Military distribution made.
- Recall initiation date
- Feb 19, 2013
- Initial firm notification
- Letter
- Center classification date
- Jun 6, 2013