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
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
Lot numbers, UPCs & expiration codes
Lot #: 10109590, 10111050, Exp 2/28/13.
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-576-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 19, 2013
- FDA report date
- Jun 12, 2013
- Quantity
- 41,400 Boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Consumer Health
Original FDA data
Every field from FDA enforcement report D-576-2013, 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 #: 10109590, 10111050, Exp 2/28/13.
- Postal code
- 68517-9626
- Report date
- Jun 12, 2013
- Product type
- Drugs
- Recall number
- D-576-2013
- Classification
- Class III
- Recalling firm
- Novartis Consumer Health
- Product quantity
- 41,400 Boxes
- 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
- 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
- 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