Recalls / Class III

Class IIID-575-2013

Product

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.

Affected lot / 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).

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

219,600 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-575-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.