FDA Drug Recalls

Recalls / Class III

Class IIID-420-2013

Product

Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, Novartis Consumer Health, Parsippany, NJ 07054, NDC 0067-6171-85

Affected lot / code info
Lot #: 10118124, Exp: Sept 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
3,828 Tubes
Distribution pattern
Nationwide

Timeline

Recall initiated
2013-04-19
FDA classified
2013-05-17
Posted by FDA
2013-05-29
Terminated
2014-11-04
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-420-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class III recall: drug · FDA Drug Recalls