Recalls / Class III
Class IIID-576-2013
Product
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
- Affected lot / code info
- Lot #: 10109590, 10111050, Exp 2/28/13.
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.
Recalling firm
- Firm
- Novartis Consumer Health
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10401 Hwy 6, N/A, Lincoln, Nebraska 68517-9626
Distribution
- Quantity
- 41,400 Boxes
- Distribution pattern
- Nationwide and Puerto Rico, and Panama. Military distribution made.
Timeline
- Recall initiated
- 2013-02-19
- FDA classified
- 2013-06-06
- Posted by FDA
- 2013-06-12
- Terminated
- 2014-11-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-576-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.