Status
Terminated
Drug Enforcement D-576-2013
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.
Classification
Class III
Report Date
June 12, 2013
Termination Date
November 26, 2014
Product Information
- 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
- Product quantity
- 41,400 Boxes
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico, and Panama. Military distribution made.
Location & Firm
- Recalling firm
- Novartis Consumer Health
- Address
-
10401 Hwy 6, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-576-2013
- Event ID
- 64372
- Recall initiation date
- February 19, 2013
- Center classification date
- June 6, 2013
- Code info
- Lot #: 10109590, 10111050, Exp 2/28/13.
- More code info
- —