Status
Terminated
Drug Enforcement D-575-2013
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
- 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.
- Product quantity
- 219,600 tubes
- 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-575-2013
- Event ID
- 64372
- Recall initiation date
- February 19, 2013
- Center classification date
- June 6, 2013
- Code info
- 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).
- More code info
- —