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Recall Observatory FDA recall evidence

Drug 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

D-576-2013

February 19, 2013

Class III

Product summary

Firm
Novartis Consumer Health
Event
Event 64372
Status
Terminated
Classification
Class III
Quantity
41,400 Boxes
Official record key
drug-enforcement:D-576-2013

Official wording

Reason: 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.

Code information: Lot #: 10109590, 10111050, Exp 2/28/13.

Distribution pattern: Nationwide and Puerto Rico, and Panama. Military distribution made.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing