FDA Drug Recalls

Recalls / Class III

Class IIID-574-2013

Product

Target Up & Up, athlete's foot cream, full prescription strength, terbinafine hydrochloride 1% antifungal, 30 g (1 oz), compare to active ingredient in Lamisil, NDC 0067-6382-30 & UPC code: 300676382302 (Novartis) Target NDC 1167-3401-04, Distributed by Target Corp., Minneapolis, MN.

Affected lot / code info
Lot numbers and exp dates: 10108716 31-Mar-2013, 10111510 30-Apr-2013, 10113801 31-May-2013, 10113839 30-Apr-2013, 10115616 31-Aug-2013

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
99,660 tubes
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-574-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.