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Recall Observatory FDA recall evidence

Drug product

4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.

D-211-2013

March 07, 2013

Class III

Product summary

Firm
Novartis Consumer Health
Event
Event 64533
Status
Terminated
Classification
Class III
Quantity
227,124 bottles
Official record key
drug-enforcement:D-211-2013

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 #: 10107922, 10108365, 10108366, 10108367, 10109874, 10110021, 10110022, 10110023, 10110024, and 10120729, Exp 3/14 to 9/14.

Distribution pattern: Nationwide and Panama

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing