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Recall Observatory FDA recall evidence

Drug product

Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC 0067-5812-96), b) 2-oz. tubes (NDC 0067-5812-86), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.

D-208-2013

March 07, 2013

Class III

Product summary

Firm
Novartis Consumer Health
Event
Event 64533
Status
Terminated
Classification
Class III
Quantity
91,872/1-oz. tubes and 94,464/2-oz. tubes
Official record key
drug-enforcement:D-208-2013

Official wording

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.

Code information: Lot #: a) 10109149, 10111499, 10117160, 10119603, and 10121763, Exp 4/13 to 8/13; b) 10109148, 10112258, 10113806, 10115615, 10117161, 10119604, 10119605, 10121782, and 10122762, Exp 3/13 to 9/13.

Distribution pattern: Nationwide and Panama

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing

Field note

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